Dataset Information

Benfotiamine and Cognitive Decline in Alzheimer's Disease: Results of a Randomized Placebo-Controlled Phase IIa Clinical Trial.

ABSTRACT:

Background

In preclinical models, benfotiamine efficiently ameliorates the clinical and biological pathologies that define Alzheimer's disease (AD) including impaired cognition, amyloid-? plaques, neurofibrillary tangles, diminished glucose metabolism, oxidative stress, increased advanced glycation end products (AGE), and inflammation.

Objective

To collect preliminary data on feasibility, safety, and efficacy in individuals with amnestic mild cognitive impairment (aMCI) or mild dementia due to AD in a placebo-controlled trial of benfotiamine.

Methods

A twelve-month treatment with benfotiamine tested whether clinical decline would be delayed in the benfotiamine group compared to the placebo group. The primary clinical outcome was the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog). Secondary outcomes were the clinical dementia rating (CDR) score and fluorodeoxyglucose (FDG) uptake, measured with brain positron emission tomography (PET). Blood AGE were examined as an exploratory outcome.

Results

Participants were treated with benfotiamine (34) or placebo (36). Benfotiamine treatment was safe. The increase in ADAS-Cog was 43% lower in the benfotiamine group than in the placebo group, indicating less cognitive decline, and this effect was nearly statistically significant (p?=?0.125). Worsening in CDR was 77% lower (p?=?0.034) in the benfotiamine group compared to the placebo group, and this effect was stronger in the APOE?4 non-carriers. Benfotiamine significantly reduced increases in AGE (p?=?0.044), and this effect was stronger in the APOE?4 non-carriers. Exploratory analysis derivation of an FDG PET pattern score showed a treatment effect at one year (p?=?0.002).

Conclusion

Oral benfotiamine is safe and potentially efficacious in improving cognitive outcomes among persons with MCI and mild AD.

SUBMITTER: Gibson GE

PROVIDER: S-EPMC7880246 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Publications

Benfotiamine and Cognitive Decline in Alzheimer's Disease: Results of a Randomized Placebo-Controlled Phase IIa Clinical Trial.

Gibson Gary E GE Luchsinger José A JA Cirio Rosanna R Chen Huanlian H Franchino-Elder Jessica J Hirsch Joseph A JA Bettendorff Lucien L Chen Zhengming Z Flowers Sarah A SA Gerber Linda M LM Grandville Thomas T Schupf Nicole N Xu Hui H Stern Yaakov Y Habeck Christian C Jordan Barry B Fonzetti Pasquale P

Journal of Alzheimer's disease : JAD 20200101 3

<h4>Background</h4>In preclinical models, benfotiamine efficiently ameliorates the clinical and biological pathologies that define Alzheimer's disease (AD) including impaired cognition, amyloid-β plaques, neurofibrillary tangles, diminished glucose metabolism, oxidative stress, increased advanced glycation end products (AGE), and inflammation.<h4>Objective</h4>To collect preliminary data on feasibility, safety, and efficacy in individuals with amnestic mild cognitive impairment (aMCI) or mild de ...[more]

PMID: 33074237

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Dataset Information

Benfotiamine and Cognitive Decline in Alzheimer's Disease: Results of a Randomized Placebo-Controlled Phase IIa Clinical Trial.

Background

Objective

Methods

Results

Conclusion

Publications

Benfotiamine and Cognitive Decline in Alzheimer's Disease: Results of a Randomized Placebo-Controlled Phase IIa Clinical Trial.

Similar Datasets

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