Sustained Improvement In Patients Research Articles

Rapid and sustained improvement of psoriasis with Bimekizumab: A real‐world case series

AbstractThis retrospective case series examines the efficacy and safety of Bimekizumab in 22 patients with moderate to severe plaque psoriasis in a real‐world clinical setting. The demographic and clinical characteristics of the participants, including a mean age of 43.7 years and a gender distribution of 60% male and 40% female, are summarised. Notably, 70% of the patients had previously received systemic therapy, and 50% had concurrent psoriatic arthritis. The evaluation over a 12‐week treatment period revealed a significant reduction in psoriasis area and severity index scores from a baseline mean of 11.5−1.0 at Week 4 and further down to 0.3 by Week 12. Similar improvements were observed in body surface area, physician's global assessment and dermatology life quality index scores. Bimekizumab was well‐tolerated with no reported adverse events, leading to no treatment discontinuations. These findings highlight the potential of Bimekizumab to provide rapid and sustained improvements in patients with moderate to severe plaque psoriasis, underlining its value in clinical practice.

Case Report: REL-1017 Reduces Abnormal Clinician Administered Dissociative States Scale Scores in Patients with Major Depressive Disorder

Dissociative symptoms may be found in a subset of patients with major depressive disorders (MDD). The Clinician-Administered Dissociative States Scale (CADSS) is a 23-item scale for the measurement of present-state dissociative symptoms with good inter-rater reliability and construct validity that can discriminate patients with dissociative disorders. The total CADSS score is derived by adding the score for each of the 23 items. A score of 4 or more on the CADSS is considered abnormal and clinically meaningful. Uncompetitive N-methyl-d-aspartic acid receptor (NMDAR) channel blockers have been proposed as a treatment for post-traumatic stress disorder (PTSD). REL-1017 is a novel, low potency, NMDAR channel blocker currently in Phase 3 studies for MDD. This retrospective case series describes a subset of patients from a double-blind, randomized, placebo-controlled, in-patient 7-day, phase 2 trial of oral, once daily, 25mg (75mg loading dose on day 1, first dose) and 50mg REL-1017 (100mg loading dose on day 1, first dose) as an adjunctive treatment for MDD. This subset of patients was selected based on abnormal CADSS score at baseline, pre-treatment with the study drug. As part of REL-1017 safety evaluation, the CADSS was administered at four timepoints to all study patients: (a) 30 to 60minutes pre-treatment at baseline on day 1; (b) 2hours post-treatment on day 1 (after the first dose of study drug); (c) 2hours post-treatment on day 7 (after the last dose); and (d) prior to discharge on day 9 (2days after the last dose). Among the 62 randomized patients, four patients had a CADSS score of at least 4 on day 1 before study drug administration (2 patients in the 25mg arm [CADSS score 22 and 4]; 1 patient in the 50mg arm [CADSS score 35]; 1 patient in the placebo arm [CADSS score 6]). Among these 4 patients, starting on day 1, 2hours post-treatment, the 2 subjects in the 25mg subgroup (75mg loading dose) and 1 subject in the 50mg subgroup (100mg loading dose) showed a clinically meaningful decrease in their CADSS score, while the single patient in the placebo group showed no change. CADSS scores on Day 1 pre-treatment, day 1 post-treatment, day 7 post last treatment, and on day 9 prior to discharge were 22-2-6-0; 4-0-0-0; 35-14-9-0, and 6-6-n/a-n/a, for the two patients in the 25mg REL-1017 subgroup, the single patient in the 50mg REL-1017 subgroup, and the single patient in the placebo group, respectively. These retrospective case report data potentially signal that REL-1017 may determine rapid and sustained improvement in patients with MDD and concurrent clinically meaningful dissociative symptoms assessed by a CADSS score of 4 or above. Ongoing phase 3 trials with REL-1017 are expected to enroll a total of 1200 outpatients with MDD. These studies will potentially generate additional data that may support the initiation of controlled studies with REL-1017 for the treatment of PTSD. Relmada Therapeutics.

Rapid Efficacy of Ixekizumab for Pediatric Acute Generalized Pustular Psoriasis

Introduction: Generalized pustular psoriasis (GPP) is a rare, severe variant of psoriasis that is uncommon in pediatric patients and can be refractory to many therapies. Ixekizumab, a monoclonal antibody that selectively inhibits interleukin 17-A, has been reported as safe and efficacious in patients with GPP, though minimal data exists on its use in the pediatric population.
 Case presentation: A 17-year-old female with history of alopecia areata and pustular psoriasis, on ustekinumab, was admitted for a severe pustular psoriasis flare with systemic symptoms including fever and tachycardia which progressed to erythroderma and required vasopressor support. After minimal improvement with 24 hours on broad-spectrum antibiotics, she received cyclosporine 5mg/kg/day. On day three of admission, and after two days of cyclosporine with minimal improvement, she received a 160 mg loading dose of ixekizumab. She defervesced and transferred out of the ICU within 24 hours. She was successfully weaned off cyclosporine after her second dose of ixekizumab. She experienced no adverse reactions.
 Discussion: Generalized pustular psoriasis is less common and often more severe than plaque psoriasis, associated with increased morbidity and mortality in both pediatric and adult patients. Clinical trials and case series have reported rapid and sustained improvement in patients with pustular psoriasis refractory to other therapies, though there is little data on the pediatric population. This case demonstrates the rapid efficacy of ixekizumab for severe erythrodermic pustular psoriasis in a pediatric patient, highlighting its use not only for refractory disease, but also as a rescue therapy in an emergent setting.

Self-management Education Program: The Case of Glycemic Control of Type 2 Diabetes.

ObjectivesSelf-management education (SME) is recognized globally as a tool that enables patients to achieve optimal glucose control. While factors influencing the effectiveness of self-management interventions have been studied extensively, the impact of program length on clinical endpoints of patients diagnosed with diabetes is underdeveloped. This paper synthesized information from the existing literature to understand the effect of program length on glycated hemoglobin (HbA1C) in adults with type 2 diabetes mellitus.MethodsWe searched Web of Science, PubMed, Scopus, MEDLINE, EMBASE, PsychINFO, and the Cochrane Central Register of Controlled Trials to identify relevant English language publications on diabetes self-management education published between January 2000 and April 2019.ResultsThe review included 25 randomized controlled trials, with 64.0% reporting significant changes in HbA1C. The studies classified as long-term (lasting one year and above) were associated with the greatest number of interventions achieving statistically significant (87.5% significant vs. 12.5% non-significant) differences in changes in HbA1C between the intervention and the control subjects, recording an overall between-group HbA1C mean difference of 0.6±0.3% (range = 0.2–1.2).ConclusionsOur findings suggest that program length may change the effectiveness of educational interventions. Achieving sustained improvements in patients’ HbA1C levels will require long-term, ongoing SME, and support.

PF603 FASTER & SUSTAINED IMPROVEMENT IN HEALTH‐RELATED QUALITY OF LIFE IN TRANSPLANT‐INELIGIBLE NEWLY DIAGNOSED MULTIPLE MYELOMA PTS TREATED WITH DARATUMUMAB, LENALIDOMIDE & DEXAMETHASONE (D‐RD) VS RD: MAIA

Background:MAIA, an ongoing phase 3 trial of transplant‐ineligible patients with NDMM, demonstrated significant improvement in progression‐free survival with D‐Rd vs Rd alone. Assessment of patient‐reported outcomes (PRO) alongside efficacy endpoints provides patient perspective on their quality of survival and overall value of health‐related quality of life (HRQoL) while on treatments.Aims:To utilize PRO assessments as a tool in capturing the patient perspective on quality of survival and HRQoL changes in MAIA.Methods:The EORTC QLQ‐C30 and EQ‐5D‐5L questionnaires were completed by patients using an electronic device at baseline and every 3 months during treatment; interim results are presented for first 12 months. Treatment effects were assessed using repeated measures, mixed effects models and thresholds for clinically meaningful benefit were based on established criterion from the literature.Results:Compliance rates in completing the assessment tools were high and comparable at baseline (>90%) and through month 12 (>80%) for both groups (D‐Rd [n = 368]; Rd [n = 369]). Improvement in Global Health Status (GHS) occurred in both groups; however, for D‐Rd, significantly greater improvement was observed at cycle 3 (LS mean change; D‐Rd: 4.5 [95% CI: 2.4, 6.6], Rd: 1.5 [95% CI: −0.7, 3.7]; [p = 0.0454]) and increasing improvement occurred across all time points. Significant improvement and clinically meaningful benefit in HRQoL for D‐Rd was also observed in EQ‐5D‐5L Visual Analog Scale (VAS) scores (LS mean change; D‐Rd: 10.1 [95% CI: 8.1, 12.1], Rd: 4.9 [95% CI: 2.8, 7.0]; [p = 0.0002]). The VAS median time to worsening was 10 mo longer for D‐Rd. Of note, meaningful differences were observed between the treatment groups in two subscale scores, pain symptoms and cognitive functioning. Statistically significant less pain was reported early with D‐Rd (LS mean change at cycle 3; D‐Rd: −17.9 [95% CI: −20.7, −15.0], Rd: −11.0 [95% CI: −14.0, −8.1]; [p = 0.0007]); clinically meaningful reduction in pain symptoms was sustained with D‐Rd. There was a decline in cognitive functioning through Cycle 12 in both treatment arms with the peak difference occurring at Cycle 9, but mean differences between groups were not statistically significant.Summary/Conclusion:Faster and sustained improvement in patients treated with D‐Rd was observed using HRQoL assessments compared with Rd, with similar findings reflected across the pain subscale.

Persistence of Efficacy of 0.1% Cyclosporin A Cationic Emulsion in Subjects with Severe Keratitis Due to Dry Eye Disease: A Nonrandomized, Open-label Extension of the SANSIKA Study

PurposeResults from a 6-month double-masked and a 6-month open-label study (SANSIKA) established the efficacy and safety of once-daily 0.1% cyclosporin A cationic emulsion (CsA CE) in severe keratitis due to dry eye disease (DED). This article presents results from the Post-SANSIKA study, a 24-month extension of SANSIKA assessing the sustained efficacy of CsA CE after treatment discontinuation. MethodsTime to relapse (corneal fluorescein staining [CFS] score ≥4 [modified Oxford scale]) was assessed after treatment discontinuation in patients from the SANSIKA study who had CFS improvement from a score of 4 to ≤2 after 6 or 12 months of treatment with CsA CE. FindingsOf 62 patients who achieved a CFS score ≤2 at the end of the SANSIKA study, 38 did not relapse and 24 (39%) relapsed during the 24-month period after CsA CE discontinuation; the latter (relapse) group comprised 35% of patients initially treated with CsA CE for 12 months in SANSIKA versus 47% of those treated for 6 months only. Patients spent the most time during the extension study at CFS scores of 1 or 2 (median duration of 8.5 weeks and 14.7 weeks per year, respectively), indicating marked improvement, and less time at scores of 3, 4, or 5 (median time, 2.0 weeks, 0 weeks, and 0 weeks per year). Of 23 patients eligible for safety analysis (ie, patients who received the study treatment at least once), 12 (52.2%) reported a total of 26 ocular adverse events (AEs). Among these, 5 ocular AEs, reported in 5 patients (21.7%), were considered related to study treatment: 3 events of mild instillation site pain in 3 patients (13.0%) and eye discharge and foreign body sensation, each reported in 1 patient (4.3%). Only 1 systemic AE (nasal congestion), reported in 1 patient (4.3%), was considered related to study treatment. None of the AEs led to treatment discontinuation. ImplicationsThe majority of patients who discontinued CsA CE after experiencing DED improvement in the SANSIKA study did not experience a relapse in this 24-month follow-up study; these patients spent the most time at CFS scores consistent with marked improvement. CsA CE had a favorable safety/tolerability profile over 2 years. Treatment for up to 12 months with CsA CE provides sustained improvements in patients with severe keratitis due to DED. EudraCT registration no. 2012-002066-12.

Disturbed Consciousness and Coma: Diagnosis and Management of Intracranial Hypotension Caused by a Spinal Cerebrospinal Fluid Leak

The diagnosis and treatment of intracranial hypotension associated with a spinal cerebrospinal fluid (CSF) leak, especially in comatose patients, have yet to be established. Clinical manifestations, neuroimaging findings, and treatment outcomes in 11 patients (Glasgow Coma Scale score 10 ± 4) were described and compared with 36 patients with normal consciousness. Patients with disturbed consciousness were diagnosed at a significantly older age (55 ± 11 years; P < 0.001) than those without (42 ± 8.8 years). Neuroimaging findings in patients with disturbed consciousness were characterized by a smaller midbrain-pons angle (7.8 ± 10°; P < 0.001), brainstem swelling (122%; P= 0.002), and thicker subdural hematomas (16 ± 7.0 mm°; P < 0.001). Epidural blood patch (EBP) alone did not achieve sustained improvements in patients with disturbed consciousness but did in most patients without (94%; P= 0.001). Over the treatment course, 5 patients progressed to coma, which correlated with a high signal intensity on T2-weighted magnetic resonance imaging in the brainstem. Hematoma drainage before EBP caused neurologic deterioration in 2 patients. Simultaneous EBP after hematoma drainage achieved sustained improvements in 5 of 6 patients. Simultaneous microsurgical dural repair after hematoma drainage achieved more rapid improvements in 3 of 3 patients. Among patients with intracranial hypotension caused by a spinal CSF leak, disturbed consciousness may occur in elderly patients because of severe diencephalic-mesencephalic deformities. Simultaneous EBP after safe hematoma drainage is indicated for these patients. Alternatively, dural repair is indicated for patients for whom the spinal level of dural disease has been identified. Hematoma drainage before EBP is not recommended because it caused deterioration.

Changes in attitude towards LAI antipsychotic maintenance treatment: A two-year follow-up study

BackgroundTo present real-world evidence on the effects of switching from oral to long-acting injectable (LAI) antipsychotic maintenance treatment (AMT) in a sample of clinically stable patients with schizophrenia, with regard to subjective experience of treatment, attitude towards drug and quality of life. Methods50 clinically stable adult schizophrenic outpatients were recruited. At the time of enrolment (T0), all patients were under a stabilized therapy with a single oral second-generation antipsychotic (SGA) and were switched to the equivalent maintenance regimen with the long-acting formulation of the same antipsychotic. 43 patients completed the 24-month prospective, longitudinal, open-label, observational study. Participants were assessed at baseline (T0), after 12 (T1) and 24 months (T2), using psychometric scales (PANSS, YMRS and MDRS) and patient-reported outcome measures (SWN-K, DAI-10 and SF-36). ResultsThe switch to LAI-AMT was associated with a significant clinical improvement at T1 and T2 compared to baseline (T0). All of the psychometric indexes, as well as patients’ subjective experience of treatment (SWN-K), and quality of life (SF-36) showed a significant improvement after one year of LAI-AMT, with stable results after two years. Patients’ attitude towards drug (DAI-10) increased throughout the follow-up period, with a further improvement during the second year. ConclusionsThe switch to LAI-AMT may help to address the subjective core of an optimal recovery in stabilized schizophrenic patients. A sustained improvement in patients’ attitude towards drug may help to achieve patient’s compliance. The size of this study needs to be expanded to produce more solid and generalizable results.

Sustainability of a nurse-driven early progressive mobility protocol and patient clinical and psychological health outcomes in a neurological intensive care unit

ObjectivesTo determine sustainable impact of an early progressive mobility protocol on mobility level and clinical outcomes. Design/MethodsProspective, longitudinal, comparative study using three time points (pre-, immediate post-intervention and 12-month post-intervention sustainability). Analyses included comparative statistics and multivariable modelling. Data were collected by clinical nurses, from administrative databases. Psychological health data were collected using a valid, reliable tool. SettingPatients treated in a 22-bed Neurological Intensive Care Unit of a quaternary-care medical centre. Outcome measuresHighest mobility level, length of stay, mortality, discharge disposition, quality metrics and psychological profile including depression, anxiety, and hostility. ResultsAmongst 260 pre-intervention, 377 post-implementation, and 480 twelve-month post-implementation patients (N = 1117) walking increased post-implementation and was sustained at the eight-month assessment, p < .001. After multivariable adjustment, unit and hospital length of stay and psychological distress were reduced compared to the pre-early mobility programmes (all p < .001). There were no differences in discharge disposition (i.e., home vs skilled nursing facility), mortality or quality metrics. ConclusionOngoing implementation of an early mobility programme in a neurological intensive care environment led to sustained improvement in patients’ level of mobility, length of unit and hospital stay, depression, anxiety and hostility levels.

Significant and Sustained Improvement in Patients with Post-Traumatic Disorder Following Single-Remedy Simillimum Prescriptions

Introduction: An evaluation of long-term outcomes of patients in our practice revealed that true simillimum prescriptions did not require any change of remedy for a sustained and comprehensive curative effect. This curative effect extended beyond physical symptoms to profound psychological improvements in patients with major depressive and post-traumatic disorders.

Is repeat Botulinum Toxin A injection valuable for neurogenic detrusor overactivity-A systematic review and meta-analysis.

To investigate the value of repeat botulinum toxin A (BTX-A) injections in patients with neurogenic detrusor overactivity (NDO). We searched the PubMed, EMBASE, and EBSCO databases for articles published until June 2016. Studies that reported the efficacy and safety of repeat BTX-A injections for adult patients with NDO were eligible. The effect size for each outcome was calculated as the standardized mean difference ± standard error and 95% confidence interval, and was graded as small, >0.2; moderate, >0.5; or large, >0.8. The outcomes included maximum cystometric capacity (MCC), maximum detrusor pressure (MDP), reflex volume (RV), bladder compliance (BC), quality of life (QOL), and injection interval. Descriptive reviews were performed for urinary incontinence (UI) and adverse events (AEs). Eighteen studies involving 1533 patients whose level of evidence ranged from 3 to 4 were included in this study. We noted non-significant changes in MCC, MDP, RV, and BC between the first and last injections. Patients who had received ≤4 injections were found to have stable QOL improvements after the first and last injections, whereas patients who had received ≥5 injections were found to have a significant decrease in QOL after the last injection. No significant differences in injection intervals were noted after repeat BTX-A injections, and the repeat injection failure rate was low. Our study demonstrated that repeat BTX-A injections allow sustained improvements in patients with NDO. The rate of AEs was stable and low. However, additional high-quality, large-scale, and long-term trials are necessary to establish the efficacy and safety of ≥5 repeat BTX-A injections.

Absconding: reducing failure to return in adult mental health wards

Failing to return from leave from acute psychiatric wards can have a range of negative consequences for patients, relatives and staff. This study used quality improvement methodology to improve the...

Community Health Education at Student-Run Clinics Leads to Sustained Improvement in Patients’ Hepatitis B Knowledge

While student-run clinics are often important healthcare safety nets for underserved populations, their efficacy for improving patient health knowledge has not been thoroughly explored. From September 2011 to April 2012, we assessed patients' retention of hepatitis B virus (HBV) knowledge after receiving student-led education at two student-run HBV screening and vaccination clinics. Patient education was provided by trained first and second-year medical, nursing, and pharmacy students, aided by a script and interpreters. Patient knowledge of HBV was evaluated at three points: before education, after the initial visit, and at one-month follow-up. Student-led education produced improved knowledge of HBV transmission, prevention, and management, which was retained 1 month after education for 52 patients tracked through time. Mean scores on an HBV knowledge survey improved from 56.4 % (SD = 15.2 %) at baseline to 66.6 % (SD = 15.1 %) after education, and 68.3 % (SD = 15.2 %) after one month. There was a statistically significant difference between the first and second (paired T test, p < 0.001) and the first and third tests (paired T test, p < 0.001), but no difference between the second and third tests (paired T test, p = 0.45). Multivariate analysis demonstrated that retention was correlated with patient educational background but independent of patient age, gender, income, primary language and number of years lived in the United States. Our study suggests that trained health professional students can effectively impart health knowledge that is retained by patients for at least 1 month. These results warrant consideration of student-led educational sessions at SRCs as a promising community health education model.

Prospective Evaluation of Autologous Chondrocyte Implantation Procedure: Minimum Seven-Year Follow-Up (SS-26)

Introduction Autologous chondrocyte implantation (ACI) shows promising short and intermediate-term results for the treatment of full thickness cartilage defects in the knee. However, the long-term outcomes of the procedure are not well described. The purpose of this study is to report the clinical outcomes following ACI from a single orthopedic surgeon at a minimum of 7 years' follow-up using validated outcome scores and physical examination. Methods 29 patients were contacted at minimum 7 years postoperatively after a retrospective review between 1998 and 2003. Patients without preoperative data and reliable contact information were excluded from the study. IKDC, Tegner-Lysholm, KOOS, SF-12, verified outcome measures were collected both preoperatively and postoperatively. Preoperative data was compared to 2-, 4-, and 7-year postoperative outcomes to assess the durability of the implant over time. Pre-specified subgroup analysis of subjective scores was also assessed. In order to obtain objective data, all 29 patients enrolled in the study were recruited to undergo a 7-year postoperative physical examination by a sports medicine fellow. Results The mean patient follow-up was 8.36 years. All lesions were grade-IV, with a mean lesion size of 3.50 cm 2 . Mean IKDC, Lysholm, SF-12 physical/mental, all KOOS (pain, symptoms, activities of daily living, sports, quality of life) scores improved significantly (p 2 ) (n=4) reported significantly lower 7-year postoperative scores on Tegner-Lysholm and KOOS-ADL measures than non-obese patients (BMI 2 ) (n=25), and patients undergoing concomitant meniscal transplant (n=5) showed significant improvements in IKDC scores. Physical exam (n=16) findings were insignificant except for crepitus noted in 8 patients and mild focal chondral tenderness was also noted in 8 patients. Conclusion Validated subjective scores demonstrated significant and sustained improvement in patients at a 2-, 4-, and 7-year follow-up. Similarly, objective data reported decreased levels of tenderness and increased functional ability. The data supports that ACI is a durable long-term treatment for patients with symptomatic full-thickness cartilage lesions and can reduce pain, increase range of motion, and improve joint function. Subgroup analysis suggests a possible connection between meniscal stability and long-term ACI efficacy as well as obesity as an indicator of poorer prognosis. An advantage of this study compared to other long-term follow up studies is that we reduce confounding due to differing surgical performance by collecting data from patients treated by a single surgeon. Like similar long-term studies, limitations include a small patient population and lack of a control group. The results of an ACI in patients who present with symptomatic chondral defects remain durable at a minimum of 7-year follow-up with persistent, high levels of patient satisfaction.

Efficacy and safety of tiotropium Respimat&amp;reg; SMI in COPD in two 1-year randomized studies

Two 1-year studies evaluated the long-term efficacy and safety of tiotropium 5 or 10 microg versus placebo, inhaled via the Respimat Soft Mist Inhaler (SMI). The two studies were combined and had 4 co-primary endpoints (trough FEV(1) response, Mahler Transition Dyspnea Index [TDI] and St George's Respiratory Questionnaire scores all at week 48, and COPD exacerbations per patient-year). A total of 1990 patients with COPD participated (mean FEV(1): 1.09 L). The mean trough FEV(1) response of tiotropium 5 or 10 microg relative to placebo was 127 or 150 mL, respectively (both P < 0.0001). The COPD exacerbation rate was significantly lower with tiotropium 5 microg (RR = 0.78; P = 0.002) and tiotropium 10 microg (RR = 0.73; P = 0.0008); the health-related quality of life and Mahler TDI co-primary endpoints were significantly improved with both doses (both P < 0.0001). Adverse events were generally balanced except anticholinergic class effects, which were more frequent with active treatment. Fatal events occurred in 2.4% (5 microg), 2.7% (10 microg), and 1.6% (placebo) of patients; these differences were not significant. Tiotropium Respimat SMI 5 microg demonstrated sustained improvements in patients with COPD relative to placebo and similar to the 10 microg dose but with a lower frequency of anticholinergic adverse events.

Etanercept, given for 10 months, provides sustained improvement in patients with ankylosing spondylitis,

Etanercept, given for 10 months, provides sustained improvement in patients with ankylosing spondylitis,

Dopaminergic augmentation of sleep deprivation effects in bipolar depression

Total sleep deprivation (TSD) has been used in association with lithium salts and with serotonergic and noradrenergic antidepressants, leading to sustained improvements in patients affected by major depression. Current theories on the neurobiological mechanism of action of TSD propose a major role for enhanced dopamine activity. To test the clinical relevance of dopaminergic enhancement in TSD, we treated a homogeneous sample of 28 bipolar depressed patients with three cycles of TSD combined with placebo or with the dopaminergic antidepressant amineptine. Changes in mood over time were rated with self-administered visual analogue scales and with the Montgomery–Åsberg Depression Rating Scale. Patients showed improved mean daily-mood scores after TSD, an effect that was highest at the first cycle and decreased with treatment repetition. Amineptine enhanced the effects of TSD on perceived mood during the first two TSD cycles, but patients in the placebo and amineptine groups showed comparable results at the end of the treatment. Despite its theoretical importance, the clinical usefulness of combining TSD with a dopaminergic agent must be questioned.

Sustained improvements in patients with dementia of Alzheimer's type (DAT) 6 months after termination of Cerebrolysin therapy.

The present study is an extension of the work of Rüther et al. (1994). 101 patients suffering from DAT were evaluated 6 months after completion of a 4 week (5 days per week) therapy with either 30 ml Cerebrolysin or placebo. The significant and clinically relevant improvements in the global rating (CGI), clinical symptomatology (SCAG), cognitive performance (ZVT-G) as primary efficacy variables, as well as the improvements in the secondary efficacy variables activities of daily living (NAI) and wellbeing (Bf-S), achieved in the Cerebrolysin group after only 4 weeks of active therapy, were maintained to a large extent during the follow-up period. Although there was a moderate tendency in the drug group towards loss of improvement, the differences between baseline and follow-up examination, as well as the differences between the verum and the placebo group, clearly document a sustained improvement in patients treated with Cerebrolysin in the first 4 weeks of the study period. It can be speculated that relatively short treatment courses with Cerebrolysin in patients suffering from neurodegenerative dementia can lead to long term influence on disease progression, which is in accordance with the proposed neurotrophic - nerve growth factor like - mode of action.