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[P4–572]: INTERIM REPORT OF A PHASE 2 PILOT SAFETY AND EFFICACY TRIAL OF GM‐CSF/LEUKINE ® IN MILD‐TO‐MODERATE ALZHEIMER'S DISEASE
Author(s) -
Potter Huntington,
Woodcock Jonathan H.,
Boyd Timothy,
Sillau Stefan H.,
Bettcher Brianne M.,
Daniels Joseph,
Heffernan Kate S.,
Gray Helen
Publication year - 2017
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.2017.07.735
Subject(s) - medicine , adverse effect , placebo , rheumatoid arthritis , clinical trial , gastroenterology , pathology , alternative medicine
change in the co-primary measures of ADAS-Cog13 (F1⁄40.18, p1⁄40.83) and SRT total recall (F1⁄40.06, p1⁄40.9). Four patients were diagnosed with probable Alzheimer’s disease by end-trial. Apolipoprotein E e4 allele and MRI hippocampal volume were unrelated to differences in outcomes between donepezil and placebo. Periventricular hyperintensities (PVH) did not distinguish changes in cognition on donepezil from placebo on ADAS-Cog13 (F1,39 1⁄4 0.14, p1⁄4 0.71) but did on SRT total recall (F1,39 1⁄4 4.23, p1⁄4 0.04); less PVH was associated with greater improvement with donepezil on SRT total recall. Conclusions: In patients with comorbid depression and cognitive impairment, the addition of donepezil following antidepressant medication treatment did not improve cognition compared to placebo, though donepezil treatment was associated with better cognition in patients with less cerebrovascular disease. The findings add to those from studies in mild cognitive impairment without depression that have not demonstrated superiority for CheI over placebo in improving cognition.