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Abstract
BackgroundHealthy aging is associated with a decline in multiple functional domains including perception, attention, short and long-term memory, reasoning, decision-making, as well as cognitive and motor control functions; all of which are significantly modulated by an individual’s level of alertness. The control of alertness also significantly declines with age and contributes to increased lapses of attention in everyday life, ranging from minor memory slips to a lack of vigilance and increased risk of falls or motor-vehicle accidents. Several experimental behavioral therapies designed to remediate age-related cognitive decline have been developed, but differ widely in content, method and dose. Preliminary studies demonstrate that Tonic and Phasic Alertness Training (TAPAT) can improve executive functions in older adults and may be a useful adjunct treatment to enhance benefits gained in other clinically validated treatments. The purpose of the current trial (referred to as the Attention training for Learning Enhancement and Resilience Trial or ALERT) is to compare TAPAT to an active control training condition, include a larger sample of patients, and assess both cognitive and functional outcomes.Methods/designWe will employ a multi-site, longitudinal, blinded randomized controlled trial (RCT) design with a target sample of 120 patients with age-related cognitive decline. Patients will be asked to complete 36 training sessions remotely (30 min/day, 5 days a week, over 3 months) of either the experimental TAPAT training program or an active control computer games condition. Patients will be assessed on a battery of cognitive and functional outcomes at four time points, including: a) immediately before training, b) halfway through training, c) within forty-eight hours post completion of total training, and d) after a three-month no-contact period post completion of total training, to assess the longevity of potential training effects.DiscussionThe strengths of this protocol are that it tests an innovative, in-home administered treatment that targets a fundamental deficit in adults with age-related cognitive decline; employs highly sensitive computer-based assessments of cognition as well as functional abilities, and incorporates a large sample size in an RCT design.Trial registrationClinicalTrials.gov identifier: NCT02416401.
Highlights
Healthy aging is associated with a decline in multiple functional domains including perception, attention, short and long-term memory, reasoning, decision-making, as well as cognitive and motor control functions; all of which are significantly modulated by an individual’s level of alertness
We will examine whether a novel alertness training approach (TAPAT) will benefit attention and executive functions in older adults, as previously shown in acquired brain injury
We hypothesize that the Tonic and Phasic Alertness Training (TAPAT) group will show greater benefits in these cognitive domains relative to an active control group and that these benefits will transfer to improvements in functional abilities
Summary
Several therapeutic approaches to improve age-related cognitive decline have been developed, including compensatory strategies We will examine whether a novel alertness training approach (TAPAT) will benefit attention and executive functions in older adults, as previously shown in acquired brain injury. Potential participants will meet with the Site’s designated team member for consent and potential enrollment During this visit, the qualified study staff authorized by the Site Principal Investigator and the potential participant will discuss the contents of the consent form, including but not limited to, the nature of the trial, the purpose of the research, the trial procedures, the possible risks and benefits of participation, randomization, confidentiality and communicate the voluntary nature of participation in the trial emphasizing the participant’s right to withdraw from the trial at any time.
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