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O1‐12‐03: SPERMIDINE SUPPLEMENTATION TO IMPROVE EPISODIC MEMORY IN AGING ADULTS AT RISK OF DEMENTIA
Author(s) -
Wirth Miranka,
Benson Gloria,
Schwarz Claudia,
Köbe Theresa,
Stekovic Slaven,
Madeo Frank,
Flöel Agnes
Publication year - 2018
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.2018.06.2398
Subject(s) - spermidine , placebo , episodic memory , hippocampus , donepezil , cognitive decline , dementia , psychology , polyamine , mnemonic , neuroscience , medicine , cognition , biology , disease , pathology , biochemistry , alternative medicine , enzyme , cognitive psychology
BI 409306 (10–50 mg) or placebo daily for 12 weeks. The primary endpoint was the change from baseline atWeek 12 in the Neuropsychological Test Battery total score. Secondary endpoints included the change from baseline at Week 12 in the Clinical Dementia Rating – Sum of Boxes (CDR-SB) and the AD Assessment Scalecognitive subscale (ADAS-Cog11) total score. AD Cooperative Study/Activities of Daily Living (ADCS-ADL) for mild cognitive impairment (ADCS-MCI-ADL) in Study 1, and ADCS-ADL in Study 2 were also assessed as secondary endpoints. Data from both studies were pooled, and analyzed using mixed model repeated measurement. Adverse events (AEs) were recorded. Results:Overall, 457 patients were randomized. The results obtained from the pooled analysis gave no indication of a treatment benefit for BI 409306 compared with placebo, with similar findings observed for the individual studies. BI 409306 was generally well tolerated. The highest frequency of AEs occurred in the BI 409306 50-mg dose group. Safety findings for the individual studies were also consistent with those from the pooled analysis. Conclusions: No clinically meaningful changes from baseline were observed across a range of BI 409306 doses administered to patients with prodromal or mild AD. Funding: Boehringer Ingelheim.