Tier 2 — strong

An open-label, 24-week pilot study of the methyl donor betaine in Alzheimer disease patients

D Knopman, M Patterson
Alzheimer disease and associated disorders 2001 15(3):162-165

Bibliography

PubMed
PMID 11522934
DOI
10.1097/00002093-200107000-00008
Funding
Funding was not specified in the indexed record or accessible funding metadata.
Competing interests
A competing-interest declaration was not available in the indexed record or accessible disclosure metadata.

Study snapshot

DesignOpen-label pilot
ModelHuman participants
Sample8 patients with mild Alzheimer disease; 7 completed
InterventionBetaine 3 g twice daily added to stable donepezil
Duration24 weeks
EndpointsCognition; Clinical change; Tolerability

What the study showed, in plain terms

Published in 2001, this source examined brain health and combination interventions. Design: Open-label pilot. Sample/model: 8 patients with mild Alzheimer disease; 7 completed. The exposure or intervention was Betaine 3 g twice daily added to stable donepezil. Follow-up or treatment period: 24 weeks.

Several participants worsened on cognitive or clinical measures. The uncontrolled design did not allow an efficacy conclusion.

Eight patients without a comparator cannot establish cognitive benefit; a myocardial infarction caused one withdrawal and other events were reported without proof of causation.

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Key findings

  • Several participants worsened on cognitive or clinical measures.
  • The uncontrolled design did not allow an efficacy conclusion.
  • The recorded outcome domains were Cognition; Clinical change; Tolerability.
  • The result applies to the tested exposure: Betaine 3 g twice daily added to stable donepezil; 24 weeks.

What this study can and cannot tell us

  • Eight patients without a comparator cannot establish cognitive benefit; a myocardial infarction caused one withdrawal and other events were reported without proof of causation.
  • Without a sufficiently blinded concurrent control, time effects, expectations, co-interventions and regression toward the mean can explain part of an apparent improvement.
  • Source basis: Indexed abstract and bibliographic data. Missing method details, funding information or participant denominators are not inferred.

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Editorial review

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Dr. Khaled Mahmoud, MBBChCritical Care Medicine, Longevity Science & Editorial Direction Dr. Amr Yasser, PhDCardiometabolic, Musculoskeletal, Gut & Bioavailability Dr. Abdulla Mostafa, PhDCellular Senescence, Neurological, Mitochondrial & Brain-Ageing Biology