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P1‐376: PERFORMANCE OF ADULTS WITH DOWN SYNDROME (DS) ON COGNITIVE AND BEHAVIORAL TESTS: BASELINE DATA FROM A PHASE 2A STUDY OF THE INVESTIGATIONAL AGENT ELND005 (SCYLLO‐INOSITOL)
Author(s) -
Kesslak Patrick,
Lott Ira,
Fan Frank,
Bairu Menghis,
Wesnes Keith Andrew,
Abushakra Susan R.
Publication year - 2014
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.2014.05.618
Subject(s) - dementia , psychology , cognition , clinical dementia rating , vineland adaptive behavior scale , effects of sleep deprivation on cognitive performance , cognitive decline , rating scale , clinical psychology , psychiatry , medicine , disease , cognitive impairment , developmental psychology
Data collected for a maximum of 12 months were analyzed for this interim report. The data of first-time treated patients with baseline MMSE scores from 10-26 in the J-GOLD study were selected to satisfy one of the enrollment criteria for the Phase 3 trial (E2020-J081-162) conducted from 1996 to 1999.Results: Efficacy analysis was performed on data from 978 patients in the J-GOLD study and 178 patients in the Phase 3 trial. The percentage of females was similar in both populations (J-GOLD, 67.2% vs. Phase 3, 66.9%). Themean patient agewas higher (79.7 vs. 67.4 years), themean disease duration was shorter (1.5 vs. 3.6 years) in the J-GOLD study than in the Phase 3 trial. The mean MMSE score increased significantly from baseline to 6 months in both populations [J-GOLD, 0.5 (p<0.001) vs. Phase 3, 0.6 (p1⁄40.032)].The mean MMSE score change from baseline to 12 months was higher in the J-GOLD study [0.17 (p1⁄40.333) vs. -1.2 (p<0.001)] than in the Phase 3 trial. Safety analysis was performed on data from 1191 patients in the J-GOLD study and from 260 patients in the Phase 3 trial. The rate of adverse drug reactions (ADRs) was 8.1% in the J-GOLD study and 27.3% in the Phase 3 trial. Conclusions: Limitations exist when comparing a clinical practice-based study with a Phase 3 trial.; however, the results showed expected efficacy and decreased ADRs in the current treatment with donepezil. Not only medical treatment, nursing, and nonmedical therapies may have progressed in the last 10 years, but also the understanding of donepezil and AD have deepened in Japan. These changes can be considered to contribute to the current results.