Sandoz Clinical Assessment Geriatric Research Articles

Efficacy and safety of Ginkgo biloba standardized extract in the treatment of vascular cognitive impairment: a randomized, double-blind, placebo-controlled clinical trial.

ObjectivesThe aim of this randomized, double-blind, placebo-controlled trial was to determine the efficacy and safety of Ginkgo biloba extract in patients diagnosed with vascular cognitive impairment (VCI).MethodsA total of 90 patients (aged 67.1±8.0 years; 59 women) were randomly allocated (1:1:1) to receive G. biloba 120 mg, G. biloba 60 mg, or placebo during a 6-month period. Assessment was made for efficacy indicators, including neuropsychological tests scores (Sandoz Clinical Assessment Geriatric Scale, Folstein Mini-Mental State Examination, Mattis Dementia Rating Scale, and Clinical Global Impression) and transcranial Doppler ultrasound findings. Safety indicators included laboratory findings, reported adverse reactions, and clinical examination.ResultsAt the end of 6-month study period, G. biloba 120 and 60 mg showed a statistically significant positive effect in comparison with placebo only on the Clinical Global Impression score (2.6±0.8 vs 3.1±0.7 vs 2.8±0.7, respectively; P=0.038). The Clinical Global Impression score showed a significant deterioration from the baseline values in the placebo group (−0.3±0.5; P=0.021) as opposed to G. biloba groups. No significant differences were found in the transcranial Doppler ultrasound findings. Adverse reactions were significantly more common and serious in the placebo group (16 subjects) than in either of the two G. biloba extract groups (eight and nine subjects, respectively), whereas laboratory findings and clinical examinations revealed no differences between the groups receiving G. biloba extract and placebo.ConclusionAccording to our results, G. biloba seemed to slow down the cognitive deterioration in patients with VCI, but the effect was shown in only one of the four neuropsychological tests administered. However, because of this mild effect in combination with a few adverse reactions, we cannot say that it is ineffective or unsafe either. Further studies are still needed to provide unambiguous evidence on the efficacy and safety of G. biloba extract.

A comparison of behavioral disturbances in Alzheimers disease(AD)and Vascular dementia(VD)

目的 比较阿尔茨海默病(AD)和血管性痴呆(VD)的精神行为症状.方法采用简易痴呆筛选量表(MMSE)、汉密尔顿抑郁量表(HAMD)、Sandoz老年临床评定量表(SCAG)、日常生活能力量表(ADL)、Nuremberg老年问卷(NAI)和哈金斯基缺血指数(HIS)对阿尔茨海默病157例及血管性痴呆150例进行测试.结果两组患者有不同程度的精神行为症状,情绪症状多见,AD组患者中有情绪症状79.6%,VD组出现情绪症状86.0%,两组患者出现多项情绪症状比较存在显著性差异(P<0.05),VD患者出现更多的情绪症状.结论 AD和VD患者精神行为症状发生率高,应予高度重视。

Prevalence of Dementia in an Urban Indian Population

This article reports the findings of a 3-year epidemiological survey for dementia in an urban community-resident population in Mumbai (Bombay), India, wherein the prevalence of all types of dementia was determined. The study was conducted in three stages. Stage 1: From a potential pool of 30,000 subjects aged 40 years or more, 24,488 (male = 11,875; female = 12,613) persons completed self-report or interviewer-rated protocols based on the Sandoz Clinical Assessment Geriatric Scale, but 5,512 (18.37%) persons refused to participate. Scores on the protocol had a possible range from 0 through 34. Stage 2: Persons with a score +2 SD above the mean were selected in this stage where the persons were screened for cognitive functioning using a modified and translated version of the Mini-Mental State Examination. Individuals who scored below the 5th percentile were included in Stage 3 and underwent a detailed neurological, psychiatric, and neuropsychological evaluation as well as hematological, radiological, electrocardiographic, and electroencephalographic investigations. Diagnoses were made jointly by a neurologist, psychiatrist, and psychologist using the DSM-IV diagnostic criteria. Subjects were also rated on the Clinical Dementia Rating (CDR) scale and assessed for activities of daily living. One hundred five subjects with dementia (CDR > or = 0.5) were identified in this population of 24,488 persons. The prevalence rate for dementia in those aged 40 years and more was 0.43% and for persons aged 65 and above was 2.44%. Seventy-eight individuals had a CDR of > or = 1 yielding an overall prevalence rate of 0.32%, and a prevalence rate of 1.81% for those aged 65 years and older. The overall prevalence rate for Alzheimer's disease (AD) in the population was 0.25%, and 1.5% for those aged 65 years and above. AD (n = 62; 65%) was the most common cause of dementia followed byvascular dementia (n = 23; 22%). There were more women (n = 38) than men (n = 24) in the AD group. Increasing age was associated with a higher prevalence of the dementia syndrome in general as well as AD specifically. In the population surveyed, the prevalence of AD and other dementias is less than that reported from developed countries but similar to results of other studies in India. Prevalence of the dementia syndrome increased with age and was not related to gender. AD was the most common dementia and the prevalence was higher in women than in men. Results are discussed with respect to shorter life expectancy, relocation of affected persons, and differences in the risk factors as compared to developed countries.

Efficacy of nicergoline in dementia and other age associated forms of cognitive impairment.

Efficacy of nicergoline in dementia and other age associated forms of cognitive impairment.

Choline alphoscerate in cognitive decline and in acute cerebrovascular disease: an analysis of published clinical data

This paper has reviewed the documentation on the clinical efficacy of choline alphoscerate, a cholinergic precursor, considered as a centrally acting parasympathomimetic drug in dementia disorders and in acute cerebrovascular disease. Thirteen published clinical trials, examining in total 4054 patients, have evaluated the use of choline alphoscerate in various forms of dementia disorders of degenerative, vascular or combined origin, such as senile dementia of the Alzheimer's type (SDAT) or vascular dementia (VaD) and in acute cerebrovascular diseases, such as transitory ischemic attack (TIA) and stroke. Analysis has assessed the design of each study, in particular with respect to experimental design, number of cases, duration of treatment and tests used to evaluate drug clinical efficacy. Most of the ten studies performed in dementia disorders were controlled trials versus a reference drug or placebo. Overall, 1570 patients were assessed in these studies, 854 of which in controlled trials. As detected by validated and appropriate tests, such as Mini Mental State Evaluation (MMSE) in SDAT and Sandoz Clinical Assessment Geriatric (SCAG) in VaD, administration of choline alphoscerate significantly improved patient clinical condition. Clinical results obtained with choline alphoscerate were superior or equivalent to those observed in control groups under active treatment and superior to the results observed in placebo groups. Analysis stresses the clear internal consistency of clinical data gathered by different experimental situations on the drug effect, especially with regard to the cognitive symptoms (memory, attention) characterising the clinical picture of adult-onset dementia disorders. The therapeutic usefulness of choline alphoscerate in relieving cognitive symptoms of chronic cerebral deterioration differentiates this drug from cholinergic precursors used in the past, such as choline and lecithin. Three uncontrolled trials were performed with choline alphoscerate in acute cerebrovascular stroke and TIA, totalling 2484 patients. The results of these trials suggest that this drug might favour functional recovery of patients with cerebral stroke and should be confirmed in future investigations aimed at establish the efficacy of the drug in achieving functional recovery of patients with acute cerebrovascular disease.

Comparison of losartan and hydrochlorothiazide on cognitive function and quality of life in hypertensive patients

We examined long-term changes in cognitive function and quality of life (QL) in hypertensive patients by comparing the antihypertensive effect of hydrochlorothiazide (HCTZ) and losartan. We studied 69 patients (age range, 30 to 73 years) with mild-to-moderate hypertension. All patients, in a double-blind study, were randomly allocated to either treatment with 50 mg losartan once daily or 25 mg HCTZ once daily. The sample in each treatment group was divided by age (younger than 60 years or 60 years or older). At baseline and after 26 months, a QL questionnaire appropriate for the hypertensive patients was given. Cognitive function was evaluated, at baseline and after 26 months, by psychometric tests consisting of items from the Mini-Mental State Examination (MMSE) and the Sandoz Clinical Assessment Geriatric (SCAG). A score of less than 24 on the MMSE and more than 40 on the SCAG was predictive of cognitive impairment. The losartan group had a significant improvement in SCAG ( P < .001) and MMSE ( P < .001). No significant changes were observed in the HCTZ group (SCAG, P = .1; MMSE, P = .2). Sixty-five percent of the elderly had a MMSE score less than 24 and 70% had a SCAG score greater than 40, v 35% and 48%, respectively, in younger patients. The health state index of QL improved significantly in both groups (losartan group, P < .01; HCTZ group, P < .02); the improvement in QL scores in patients using HCTZ was significant only in subjects aged 60 years and older ( P < .04). These results suggest that losartan can have a positive effect not only on blood pressure but also on impaired cognitive function, reversing even minimal cognitive deficits induced by hypertension. The elderly patients in our sample had worse scores and cognitive performance was lower than in younger patients, even if in the losartan group the score improvement was the same at all ages. The same could not be said for HCTZ.

Memory assessment in studies of cognition-enhancing drugs for Alzheimer's disease.

There is an increasing number of cognition-enhancing drugs for Alzheimer's Disease (AD) and, consequently, drug trials represent a growing field of interest in research. As memory dysfunction is generally the first and most severe cognitive impairment in AD, the choice of memory testing to be used in these studies is of great importance. It should reflect an understanding of memory systems being assessed with neuropsychological tests and the fact that some tests can be more appropriate than others to show benefit with certain classes of cognition-enhancing drugs. Severe deterioration of episodic and semantic memory occurs very early in the AD process while working memory shows a gradual deterioration over time. Some aspects of working and implicit memory can be spared in the mild to moderate stages of AD. Tests of working, episodic, semantic and implicit memory are used as outcomes in trials with acetylcholinesterase inhibitors, drugs with other neurotransmitter strategies, metabolic enhancers and drugs which may impact upon a variety of CNS processes. The clinical scales and observational measures are largely used in trials of cognition-enhancing drugs for AD (46.66% of all the studies reviewed). The Digit Span test, the Rey Auditory Verbal Learning Test, the Buschke Selective Reminding Test and the verbal fluency tasks are the most sensitive memory tests, whereas the most sensitive scales are the Sandoz Clinical Assessment-Geriatric, the Gottfried-Bräne-Steel scale and the Blessed Dementia Scale. Finally, we suggest that future investigations should use sensitive memory tests, together with behavioural and psychiatric scales, rather than general observational evaluations.

European Pentoxifylline Multi-Infarct Dementia Study

A double-blind, placebo-controlled, parallel-group, multicentre study was conducted to evaluate the efficacy of pentoxifylline (Trental®) in patients with multi-infarct dementia (MID) according to DSM-III-R criteria. Men and women aged 45 years or older, with a Hachinski Ischemia Scale score > 7 and a Mini Mental State Examination (MMSE) score of 10-25 at entry, and computed tomographic evidence of vascular disease were enrolled. A total of 289 patients were randomised to receive either oral pentoxifylline 400 mg t.i.d. or placebo for 9 months, and efficacy was assessed every 3 months. The primary outcome variable was the difference in scores between the two treatment groups, as measured on the Gottfries, Brane, Steen (GBS) scale. Secondary outcome variables included the scores achieved on the Sandoz Clinical Assessment Geriatric (SCAG) scale and MMSE, and a battery of psychological and other tests. The intention-to-treat analysis for patients completing the study (n = 239) showed a statistically significant difference in the total GBS score in favour of pentoxifylline (improvement of 3.5 points, p = 0.028). A significant difference in the total GBS score in favour of pentoxifylline was even almost achieved in the intention-to-treat analysis for all evaluable patients (n = 269, improvement of 2.1 points, p = 0.065). It is concluded that treatment with pentoxifylline is beneficial for patients with MID, the global results of the GBS and SCAG scales being reinforced by significant improvements in those sub-scales specific for intellectual and cognitive function.

Efficacy of Dihydroergocristine 20mg Once Daily in Patients with Organic Brain Psychosyndrome

Forty outpatients (20 men and 20 women) aged 60 to 80 years (mean age 69.9 ±5.5 years) with a diagnosis of organic brain psychosyndrome took part in a 3-month randomised, double-blind study aimed at comparing the effectiveness and safety of dihydroergocristine 20mg once daily and placebo. The patients had experienced memory impairment and reduced concentration and clarity of thought, and/or personality and affective disorders for at least 6 months. Patients had a Hachinski Dementia Score ≤15, a Hachinski Ischemic Score <5, and a Hamilton Rating Scale for Depression score of ≤22. The Sandoz Clinical Assessment-Geriatric (SCAG) scale, used as the efficacy variable, was administered on study entry and during (45 days) and after (90 days) treatment. Safety evaluations (routine laboratory tests and measurements of systolic and diastolic blood pressure and heart rate) were performed before and at the end of the study period. All patients fulfilled the entry criteria and completed the study protocol. In the dihydroergocristine group, there was a marked improvement in the SCAG total score and in most partial scores compared with baseline values. Most symptoms had already improved significantly after 45 days of treatment with dihydroergocristine.

Confirmed Clinical Efficacy of Actovegin®in Elderly Patients with Organic Brain Syndrome

A double-blind randomized clinical trial was performed comparing the therapeutic effects of Actovegin versus placebo in elderly patients with organic brain syndrome. In addition to the necessary basic internal medicine therapy, 40 geriatric patients received dialy intravenous infusions of 250 ml Actovegin 20% p.i., and 20 patients received 250 ml 0.9% saline solution as placebo over a period of four weeks. Of the patient sample, 58% were hospitalized for simple dementia (ICD-9: 290.0) and 42% due to senile dementia with depressive or paranoid symptoms (ICD-9: 290.2). Based on the Syndrome Short Test (SKT) and the Sandoz Clinical Assessment Geriatric Scale (SCAG) score, the patients suffered from mild to moderate dementia. The therapeutic effect on the total SCAG score and the Clinical Global Impression (CGI) were the primary study variables. The scores for the SCAG subscales and the SKT score served as secondary variables. The mean total SCAG score in the drug group decreased from 56.3 at the start of therapy to 36.3 points at the end of therapy, and in the placebo group the total score went from 61.2 to 52.0 (p < 0.01). The CGI showed that with Actovegin, 70% of the patients experienced "distinct improvement" or "improvement" compared to only 35% with such results in the placebo group. The SCAG subscales and the total SKT score also demonstrated the superior effects of Actovegin compared to placebo. Moreover, the therapy group treated with Actovegin showed greater improvements in social behavior and mental performance than did the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS)

Dihydroergocristine in the treatment of elderly patients with cognitive deterioration: A double-blind, placebo-controlled, dose-response study

The efficacy and safety of three dose levels of dihydroergocristine (DHEC) and placebo were compared in this double-blind, placebocontrolled, randomized study with four parallel groups. A total of 80 patients of both sexes, aged 50 years or older, with degenerative cerebral impairment and mild-to-moderate symptoms of cognitive deterioration were included in the study. All eligible patients received placebo for a run-in period of 15 days before entry into the study. They were then randomly assigned to receive one of the following treatments: DHEC 6 mg/d, DHEC 12 mg/d, DHEC 20 mg/d, or placebo for 3 months. The Sandoz Clinical Assessment Geriatric (SCAG) scale was administered on entry and after 30, 45, and 90 days of treatment; at each visit, physical examination and monitoring of adverse events were performed. Before and at the end of the study period systolic and diastolic blood pressures and heart rate were measured and samples were taken for routine laboratory tests. The four treatment groups were well matched as to sex, age, body weight, concomitant diseases and therapies, history of disease, and SCAG total scores. In all three DHEC-treated groups, a progressive improvement of symptoms, as assessed by using SCAG total scores, was observed. Clinically relevant or statistically significant differences from baseline values and a clear dose-response relationship were seen in these groups. Conversely, in the placebo group the symptoms remained almost unchanged throughout the study. The mean times to obtain a 50% reduction of all symptoms, as calculated by regression analysis of SCAG total score for each group, were significantly lower after treatment with DHEC 20 mg than after treatment with DHEC 6 mg and DHEC 12 mg; the same evaluation performed on single clusters showed a significant dose-effect relationship. Three types of adverse events were reported in 5 patients (nausea in 1 placebo patient, gastric pain in 1 patient treated with DHEC 12 mg and 1 with DHEC 20 mg, and dyspepsia in 1 treated with DHEC 6 mg and 1 with DHEC 12 mg). All symptoms were mild, short lasting, and self-limiting, except dyspepsia in the 1 patient given DHEC 12 mg, which was moderate and lasted until the discontinuation of the treatment. The results of this study confirm that DHEC is effective and safe in the treatment of patients with organic psychosyndrome and suggest the usefulness of administering the drug at 20 mg/d to patients with a high degree of cerebral impairment.

Paroxetin in der Depressionsbehandlung geriatrischer Patienten - eine doppelblinde Vergleichsstudie mit Fluoxetin

A 6-week double-blind, parallel group study compared paroxetine and fluoxetine in 106 depressed geriatric inpatients (aged 65 to 85 years). Patients presenting acutely with major depressive episode DSM-III-R 296.2 (HAMD>18 on 21 item scale) were randomized to receive paroxetine (20- 40 mg, n = 54) or fluoxetine (20-60 mg, n = 52) following a 3 -7 day washout. Primary criteria was the reduction of Hamilton Depression Rating Scale Score (HAMD). Furthermore Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression Scale (CGI) were used. Cognitive functions were assessed with the Mini-Mental-State Examination (MMSE) and the Sandoz Clinical Assessment Geriatric Scale (SCAG).

Effects of S-adenosyl-L-methionine on cognitive and vigilance functions in the elderly

Forty elderly patients with impaired cognition and vigilance functions associated with primary or secondary organic brain syndrome were treated with S-adenosyl-L-methionine (SAMe) for 2 months. Patients scoring 17 or higher on Hamilton's Rating Scale for Depression (HRSD) were excluded from the study. The SAMe dosing schedule was 400 mg intravenously during the first 20 days, 200 mg intramuscularly plus 400 mg orally twice daily for another 40 days. Examinations were performed using the Mini-Mental State Examination (MMSE) and the Sandoz Clinical Assessment Geriatric Scale (SCAG) at time 0 (baseline) and on days 20 and 60 of treatment. Statistically significant differences ( P<0.01) were observed in MMSE and SCAG total scores on day 60 versus baseline. Significant improvements were observed in 4 out of 19 items on the SCAG versus baseline on day 20, and in 13 out of 19 items versus baseline on day 60. No adverse side effects were reported.

Anxiety as a factor in agitation in the demented institutionalized elderly: Randomized single blind treatment with azapirones versus neuroleptics

Alzheimer's dementia is a disease of cognitive and behavioral abnormalities. The most common request for psychiatric intervention in residential settings for the elderly concerns agitated behaviors. Factor analysis of a host of clinical symptoms of agitated behavior in nursing homes suggested three central behaviors: physical aggression, verbal assault and inappropriate motor behavior (Cohen-Mansfield and Billig, 1986). ,~.nxiety scales and classification have not been described in this population. Of 38 moderate to severely demented non-depressed patients on chronic neuroleptic treatment ( age range 7390), identified as behavior problems by nursing, 14 were randomly switched to buspirone 15rag daily. 2 subjects became psychotic and were put on neuroleptics again. Overall, the buspirone group had behavior amelioration compared with the neuroleptic group. Over 8 weeks treatment, Zung somatic anxiety scores improved on average over 10% in the buspirone group (pc: 0.05) though Spielberger subjective anxiety scores were too variable to show reliable changes. Clinical assessment scales as the Sandoz Clinical Assessment Geriatric (SCAG) and the Nursing Observation Scale (NOSIE) showed a trend towards improvement. Sleep length increased and there was less daytime sedation. BPRS, HAMD and MMSE were essentially unchanged suggesting that psychosis, depression and cognitive functions may not be relevant to the behavioral improvement with 5 liT ! A agonists as buspirone.

The efficacy of EGb 761 in patients with senile dementia of the alzheimer type, a double‐blind, placebo‐controlled study on different levels of investigation

AbstractForty patients diagnosed as suffering from senile dementia of the Alzheimer type received either 80 mg Ginkgo biloba special extract (GBE)* or matching placebo t.i.d. for three months in a randomized, double blind study of the efficacy and tolerance of GBE. The patients were assessed using a test battery at baseline and at 1, 2 and 3 months. The test battery included the SKT (a brief test of cognitive function, memory and attention), the Sandoz Clinical Assessment Geriatric Scale, choice reaction time, saccadic eye movements and EEG. Memory and attention, as measured by the SKT, improved significantly in the active treatment group after one month, as did psychopathology, psychomotor performance, functional dynamics and neurophysiology as measured by the above tests. The drug was well tolerated and no adverse drug reactions were recorded during the trial.

A Double-Blind Study of Paroxetine Compared With Fluoxetine in Geriatric Patients With Major Depression

A 6-week, double-blind, parallel group study compared the efficacy and tolerability of paroxetine and fluoxetine in 106 depressed geriatric outpatients (age, > or = 65 years). Patients with an acute major depressive episode were randomized to receive either paroxetine (20 to 40 mg; N = 54) or fluoxetine (20 to 60 mg; N = 52) after a 3- to 7-day washout. Efficacy evaluations at weeks 1, 3, and 6 used the 21-item Hamilton Rating Scale for Depression (HAM-D). Cognitive function was assessed by use of the Mini-Mental State Examination (MMSE) and the Sandoz Clinical Assessment Geriatric Scale (SCAG). Tolerability was assessed by response to a nonleading question concerning adverse events. There were no significant differences between treatments at week 6 on the HAM-D total, change from baseline. However, there was a statistically significant difference (p < 0.05) at week 3 in favor of paroxetine. Results from the MMSE and SCAG showed that, during treatment, patients in the paroxetine group were characterized by greater improvement in cognitive function than were those in the fluoxetine group. This result was statistically significant at week 3 for both scales (p < 0.05). Adverse events occurred most frequently within the gastrointestinal and nervous systems for both drugs, with no significant differences between treatments.

Effects of oxiracetam on organic brain syndrome following activation of the high-affinity choline uptake system: A neurochemical analysis of the cerebrospinal fluid of four patients

Nootropic drugs stimulate acetylcholine (ACh) synthesis by activating the high-affinity choline uptake system. Cerebrospinal fluid (CSF) samples were obtained from four patients with organic brain syndrome in order to gauge acetylcholinesterase activity and measure levels of ACh, 5-hydroxyindoleacetic acid, vanillylmandelic acid, and 5-hydroxytryptophan before and at the end of nootropic treatment. Patients were given oxiracetam for 30 days at dosages varying from 1600 mg/day to 2000 mg/day. Clinical evaluations conducted at the beginning and end of treatment were made by measuring the Sandoz Clinical Assessment—Geriatric (SCAG) score and reaction times to simple auditory and visual stimuli. Following oxiracetam treatment, average ACh levels in CSF decreased significantly, and there was a concomitant improvement in the clinical evaluation (SCAG).

A neurotropic approach to the treatment of multi-infarct dementia using L-α-glycerylphosphorylcholine

A multicenter, unblinded, randomized, controlled clinical trial was conducted to evaluate the efficacy and tolerability of L-α-glycerylphosphorylcholine (L-α-GPC) 1 gm/day IM compared with that of cytidine diphosphocholine (CDP-choline) 1 gm/day IM in 112 patients with mild to moderate multi-infarct dementia (MID). A 90-day treatment period with the test drug was followed by a 90-day follow-up period without treatment to observe how long the results obtained with treatment could be maintained. A total of 97 patients completed the treatment period; of these, 73 completed the follow-up period. Eighteen patients did not complete the study because of poor compliance, and 21 patients at one center were not followed up. Treatments were started after a 2-week washout period during which other drugs that could affect cognitive function were withdrawn. Clinical efficacy was evaluated by comparing the results at baseline, after 30 days, at the end of treatment, and at the end of the follow-up period on the following psychometric tests: the Sandoz Clinical Assessment Geriatric (SCAG) Rating Scale, the Blessed Dementia Scale, the Blessed Information, Memory, Concentration test, the Wechsler Memory Scale (WMS), the Rapid Disability Rating Scale 2 (RDRS 2), the Word Fluency test, the Token test, and the Simple Drawing Copy (SDC). The patients receiving L-α-GPC showed a significant improvement of cognitive functions, behavior, and personality at the end of the treatment, compared with baseline values. This improvement was still apparent at the end of the follow-up period. Only aphasia, as measured by the Word Fluency test, was significantly improved by the CDP-choline treatment. A comparison of the results obtained with L-α-GPC and CDP-choline shows that the performance of the patients treated with L-α-GPC was significantly better than that of the CDP-choline group on the Blessed Dementia Scale, WMS, RDRS 2, and SDC at the end of treatment and on the Blessed Dementia Scale, WMS, SCAG, and Token test at the end of the follow-up period. Both treatments were well tolerated.

EEG Mapping and psychopharmacological studies with denbufylline in SDAT and MID

Computed tomography (CT), electroencephalograms (EEG), clinical and psychometric data were obtained in 96 mildly to moderately demented patients (72 women, 24 men), aged 61–96 years (mean 82), diagnosed according to DSM-III criteria. Patients were off drugs for at least 2 weeks and subdiagnosed according to the modified Marshall-Hachinski ischemic score and CT in 45 senile dementia of the Alzheimer type (SDAT) and 51 multiinfarct dimentia (MID) patients. Evaluations were carried out before and 12 weeks after treatment with either 100 mg denbufylline BID or placebo and included EEG mapping, the Sandoz Clinical Assessment Geriatric (SCAG) score/factors, the Clinical Global Impression (CGI), the Digit Symbol Substitution Test (DSST), the Trail-Making Test (TMT) and the Digit Span Test (DS). Descriptive data analysis including confirmatory statements found delta/theta activity enhanced, alpha and beta activity reduced, total power augmented, and the centroid slowed down over various brain regions in patients as compared with controls. The two subtypes of dementia could be differentiated in some conventional EEG variables but mostly by means of power asymmetry indices. Denbufylline induced a statistically significant and clinically relevant improvement in both SDAT and MID patients, whereas after placebo this was not the case in CGI, the TMT, and the DS, with interdrug differences being significant in all primary target variables such as the CGI, MMS, SCAG, and DSST. Thus, both the degenerative and vascular type of dementia exhibited a therapeutic benefit that could be objectified at the neurophysiological level by EEG mapping in an improvement of vigilance.

A new scale for assessing behavioral agitation in dementia

The primary purpose of the present study was to develop a reliable and valid rating instrument for assessing treatment efficacy for behavioral problems in the cognitively impaired elderly. The Behavioral and Emotional Activities Manifested in Dementia (BEAM-D) Scale was developed for the operational assessment of troublesome and disruptive behaviors in dementia. Each behavioral category of the BEAM-D was clinically considered to be a significant deviation from normative behavior for the geriatric dementia patient. The reliability and validity of the BEAM-D was assessed in a group of 45 patients diagnosed with primary degenerative dementia. The mean interrater reliability of BEAM-D items was 0.90. Concurrent validity was established by comparison with currently used rating scales, the Brief Psychiatric Rating Scale (BPRS) and the Sandoz Clinical Assessment-Geriatric (SCAG). Stepwise regression analysis revealed that the items of the BEAM-D had a strong relationship with conceptually similar behavioral dimensions on the BPRS and SCAG.