Sulbutiamine for Alzheimer's: Does it Help Memory?

Key Findings

The study found that sulbutiamine (S) combined with donepezil (D) improved episodic memory and daily living activities in patients with early-stage or moderate Alzheimer’s disease (AD), whereas donepezil alone followed by placebo (D + P) did not. Attention improved in both groups during the initial 3-month monotherapy phase, but only the S + D group showed sustained benefits in memory and functional outcomes.

Study Design

This was a multicenter, randomized, double-blind trial conducted over 6 months. Patients were divided into two groups: one received donepezil (D) for 3 months followed by donepezil + placebo (D + P) for another 3 months, while the other received sulbutiamine (S) for 3 months followed by sulbutiamine + donepezil (S + D) for 3 months. The study focused on cognitive domains (episodic memory, working memory, executive function, attention) and daily activities. Specific sample size and demographic details (e.g., age, gender) were not provided in the summary.

Dosage & Administration

The study administered sulbutiamine (S) or donepezil (D) alone for the first 3 months. In the subsequent 3 months, the D group received a placebo (D + P), while the S group continued with sulbutiamine and added donepezil (S + D). However, the exact dosages of sulbutiamine and donepezil were not specified in the provided summary.

Results & Efficacy

• Episodic Memory: Declined in the D + P group but improved in the S + D group compared to baseline.
• Attention: Improved in both groups during the initial 3 months, with sustained benefits in both groups during the second phase.
• Daily Living Activities: Improved only in the S + D group.
• Comparisons: No direct statistical comparisons between groups (e.g., p-values, confidence intervals) were reported in the summary. The analysis focused on within-group changes from baseline.

Limitations

1. Lack of Control Group: No untreated or placebo-only group was included for comparison.
2. Short Duration: The 6-month timeframe may be insufficient to assess long-term efficacy or safety.
3. Unspecified Dosages: The exact doses of sulbutiamine and donepezil were not detailed, limiting reproducibility.
4. Sample Size and Demographics: The number of participants and baseline characteristics (e.g., age, disease severity) were not provided.
5. Observational Nature: The study’s design (as noted in the source type) may limit causal inference compared to interventional trials.
6. Outcome Measures: Daily living activities were assessed without validated scales, raising concerns about measurement reliability.

Clinical Relevance

For individuals with early-stage or moderate AD, sulbutiamine may enhance the cognitive benefits of acetylcholinesterase inhibitors like donepezil, particularly for episodic memory and functional independence. However, the absence of detailed dosing, statistical metrics, and demographic data limits the strength of these conclusions. Practitioners should consider these findings as preliminary and prioritize larger, controlled trials before recommending sulbutiamine as an adjunct therapy. Patients currently using donepezil might explore sulbutiamine as a potential add-on, but under medical supervision due to the limited evidence base.

Note: This analysis is restricted to the provided study summary. Full conclusions require access to the original methodology and statistical analyses.