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P4‐354: Cognitive performance in healthy volunteers on the Cogtest computerized neurocognitive battery across cultures: Implications for clinical trials of Alzheimer's disease
Author(s) -
Bardwell Mark,
Pandey Smita,
DeSanti Susan,
Halder Susmita,
Nath Geetika,
Gupta Saurabh,
Berkowitz Linda,
Sharma Tonmoy
Publication year - 2008
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2008.05.2425
Subject(s) - neurocognitive , cognition , cognitive decline , population , cognitive test , medicine , normative , placebo , clinical trial , psychology , gerontology , disease , clinical psychology , dementia , psychiatry , philosophy , alternative medicine , environmental health , epistemology , pathology
relateddisability and long term care placement, there remarkably little large clinical trial experience in the primary prevention of dementia. We report participant adherence and retention data from the Ginkgo Evaluation of Memory Study (GEMS), a trial of the effectiveness of Ginkgo biloba in delaying the incidence of AD/all cause dementia. Objectives: The purpose of this study was to assess the utility of Ginkgo biloba 120 mg BID on delaying emergence of AD/all cause dementia. We herein provide data on adherence and retention that will be useful in planning and carrying out clinical trials in older and minority populations. Methods: A randomized, double-blind, placebo-controlled clinical trial conducted at 4 academic sites in the US. A total of 3,071 subjects age 75 with normal cognition or MCI were randomized to either Ginkgo or placebo after extensive medical and neuropsychological screening, including the Clinical Dementia Rating (CDR) performed with each participant’s proxy. Assessments, including medication compliance, were performed every 6 months and incorporated home visits, proxy interviews and telephone assessments. Results: A total of 440 persons developed dementia over the course of the study, extending 8 years from initial recruiting to last peron/last visit. At trial close out cognitive data and vital status were available on a very high percentage of participants. We will present the methods incorporated to maximize adherence and retention as well as visit and medication compliance results in this older population (Mean age 83 at end of trial). Conclusions: Dementia and cognition are assessable outcomes in primary prevention trials and adherence and retention can be maintained in at-risk elderly cohorts. Substantial information from GEMS will be of benefit to designing future prevention trials assessing medication effectiveness, and the potential incorporation of retention/compliance behaviors as an outcome or outcome modifier.