Trial results for the buntanetap/posiphen dose-ranging study (NCT05686044) in mild to moderate Alzheimer's disease were posted on ClinicalTrials.gov on 2025-04-29. The 15mg buntanetap/posiphen dose demonstrated a -3.01 units change from baseline on the ADAS-Cog11 scale, compared to -2.32 units for placebo, indicating a greater improvement in cognitive function.
Background
The study investigated buntanetap/posiphen for its efficacy and safety in participants diagnosed with mild to moderate Alzheimer's disease.
Trial design
The study (NCT05686044) was a Phase 2/Phase 3, double-blind, dose-ranging trial that enrolled 351 participants with mild to moderate Alzheimer's disease. The trial compared three different doses of buntanetap/posiphen (7.5mg, 15mg, and 30mg) against a placebo arm. The double-blind treatment duration was 12 weeks, following a screening period, with a total study duration of 4-5 months. The primary outcome measures were not specified in the posted results.
Key results
The trial evaluated several key measurements from baseline to Week 12:
- Change From Baseline to Week 12 in ADAS-Cog11 (Alzheimer's Disease Assessment Scale-Cognitive Subscale 11):
- Placebo: Least Squares Mean of -2.32 units (Standard Error: 0.533).
- 7.5mg Buntanetap/Posiphen: Least Squares Mean of -1.34 units (Standard Error: 0.526).
- 15mg Buntanetap/Posiphen: Least Squares Mean of -3.01 units (Standard Error: 0.534).
- 30mg Buntanetap/Posiphen: Least Squares Mean of -2.24 units (Standard Error: 0.531).
- ADCS-CGIC at Week 12 (Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change):
- Placebo: Least Squares Mean of 3.58 score (Standard Error: 0.129).
- 7.5mg Buntanetap/Posiphen: Least Squares Mean of 3.96 score (Standard Error: 0.128).
- 15mg Buntanetap/Posiphen: Least Squares Mean of 3.61 score (Standard Error: 0.131).
- 30mg Buntanetap/Posiphen: Least Squares Mean of 3.83 score (Standard Error: 0.132).
- Change From Baseline to Week 12 in ADCS-ADL (Alzheimer's Disease Cooperative Study - Activities of Daily Living):
- Placebo: Least Squares Mean of 2.03 units (Standard Error: 0.811).
- 7.5mg Buntanetap/Posiphen: Least Squares Mean of -0.14 units (Standard Error: 0.806).
- 15mg Buntanetap/Posiphen: Least Squares Mean of 1.71 units (Standard Error: 0.831).
- 30mg Buntanetap/Posiphen: Least Squares Mean of 0.15 units (Standard Error: 0.822).
What this means
The results indicate varying effects across the different doses of buntanetap/posiphen and outcome measures. For the ADAS-Cog11 scale, where a negative change signifies improvement, the 15mg dose of buntanetap/posiphen showed a greater reduction (-3.01 units) compared to placebo (-2.32 units), suggesting a potential cognitive benefit at this specific dose. The 7.5mg and 30mg doses showed less improvement or were comparable to placebo on ADAS-Cog11. On the ADCS-CGIC scale, lower scores indicate improvement, and the 15mg dose was similar to placebo, while the 7.5mg and 30mg doses showed higher scores, suggesting less improvement or worsening. For ADCS-ADL, where a positive change indicates improvement in daily living activities, placebo showed an improvement, while the buntanetap/posiphen doses showed less improvement or a decline. These findings suggest a complex dose-response relationship and highlight the 15mg dose as potentially beneficial for cognitive function in mild to moderate Alzheimer's disease, based on the ADAS-Cog11 outcome.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05686044, titled "A Dose-ranging Study to Investigate Efficacy of Buntanetap in Mild to Moderate AD," were posted on 2025-04-29 on clinicaltrials.gov.