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A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD
Started: Feb 4, 2025
Last Updated: Jul 15, 2025
Status
Enrolling
Phase
3
Age
55 - 85 years
Enrollment Goal
760
Study Drug:
Buntanetap (formerly Posiphen)
Key Inclusions:
MMSE 21-28
Positive for plasma pTau217
Positive for plasma pTau217
Primary Endpoints:
ADAS-Cog13
ADCS-iADL
ADCS-iADL
Clinicaltrials.gov ID:
NCT06709014
Find more information at ClinicalTrials.gov
AIMS
1. Does buntanetap improve cognition as measured by ADAS-Cog13?
2. Does buntanetap improve function as measured by ADCS-iADL?
3. What medical issues do participants have, if any, when taking buntanetap?
BRIEF SUMMARY
Participants will take buntanetap (30mg) or placebo every day for 18 months.
Participants will be required to visit clinic periodically for checkups, tests and questionnaires. The frequency of visits is the following: screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18. Additionally, volumetric MRI will be conducted at month 6 and month 18.
In addition to primary endpoints, the study will also measure MMSE, CGI-S, CDR, and volumetric MRI (hippocampus and whole brain).
The study will have a 6-month read-out to measure symptomatic improvement and a 18-month read-out to measure potential disease-modifying response.
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Ask us about our clinical trials
IRB approved Alzheimer Study Flyer: Buntanetap in Treating Alzheimer’s and Parkinson’s Disease
The data from our phase 2 study in Alzheimer’s and Parkinson’s patients was published in JPAD (Journal of Prevention of Alzheimer’s Disease) and we have attached the paper. Here is a summary of what we found and why we have progressed our drug into phase 3.
Buntanetap is an orally available small molecule that inhibits the translation of multiple neurotoxic aggregating proteins only under conditions where their translation is elevated – in sick nerve cells. Because it only affects these neurotoxic proteins when they are overexpressed, it restores their normal levels without affecting other proteins and restores homeostasis in the brain.
Both Alzheimer’s disease and Parkinson’s disease have been shown to have mixed pathology and mixed proteinopathy. All four neurotoxic aggregating proteins are present in the brain of Alzheimer and Parkinson patients – Aβ forms plaques, tau forms tangles, alpha-synuclein forms Lewy bodies, and TDP43 forms its aggregates.
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