NCT06709014

A 6-month & 18-month Prospective, Randomized, Placebo-controlled, Double-blind Dual Clinical Trial Investigating Efficacy and Safety of Buntanetap in Treating Participants of Early Alzheimer's Disease

Active, enrolled Phase 3 Last updated 14 May 2026

What this trial tests

Phase 3 trial testing buntanetap/posiphen in Early Alzheimers Disease in 760 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 February 2025

Primary endpoint
1 December 2027

1 June 2028

Quick facts

Lead sponsor	Annovis Bio Inc.
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	760
Start date	4 February 2025
Primary completion	1 December 2027
Estimated completion	1 June 2028
Sites	78 locations across United States

Drugs / interventions tested

• buntanetap/posiphen — full drug profile →
• Placebo

Conditions studied

• Early Alzheimers Disease — all drugs for Early Alzheimers Disease →

Sponsor

Annovis Bio Inc. — full company profile →

Who can join

Adults 55 to 85, any sex, with Early Alzheimers Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13)
  Time frame: From screening to 6-month readout, to end of treatment at 18 months.
  ADAS-Cog13 includes the original ADAS-Cog11 items that assess cognitive function across the memory, language, praxis, and orientation domains and adds a number cancellation task and a delayed free recall task. Total scores range from 0-85, with higher scores indicating greater cognitive impairment.
• Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL)
  Time frame: From screening to 6-month readout, to end of treatment at 18 months.
  The Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL) is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's study partner to assess function to the degree to which the participant can perform a variety of tasks. The questionnaire asks 6 questions of basic ADLs and 17 instrumental ADLs. The iADL are more complex tasks, i

Sponsor's own description

The goal of this clinical trial is to learn if buntanetap/Posiphen works to treat early Alzheimer's disease in adults aged 55-85. It will also learn about the safety of buntanetap/Posiphen. The main questions it aims to answer are:

* Does buntanetap/Posiphen improve cognition as measured by ADAS-Cog13?
* Does buntanetap/Posiphen improve function as measured by ADCS-iADL?
* What medical issues do participants have, if any, when taking buntanetap/Posiphen?

Researchers will compare buntanetap/Posiphen to a placebo (a look-alike substance that contains no drug) to see if buntanetap/Posiphen works to treat early Alzheimer's disease.

Participants will:

* Take buntanetap/Posiphen or a placebo every day for 18 months
* Visit the clinic periodically for checkups, tests, and questionnaires (screening visits, enrollment, month 1, month 3, month 6, month 9, month 12, month 15, month 18), including a volumetric MRI at month 6 and month 18
* Complete pre- and post-clinic visit phone calls

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Revisiting the therapeutic landscape of tauopathies: assessing the current pipeline and clinical trials.
   Harris GA, Hirschfeld LR, Gonzalez MI, Pritchard MC, et al · · 2025 · cited 8× · PMID 40462159 · DOI 10.1186/s13195-025-01775-x
2. Alzheimer Combination Therapies: Overview and Scenarios.
   Cummings JL, Burstein AH, Fillit H. · · 2025 · cited 6× · PMID 41145337 · DOI 10.1016/j.tjpad.2025.100328
3. Tau-Targeted Therapeutic Strategies: Mechanistic Targets, Clinical Pipelines, and Analysis of Failures.
   Shen X, Li H, Zhang B, Li Y, et al · · 2025 · cited 1× · PMID 41090735 · DOI 10.3390/cells14191506
4. Alzheimer's disease drug development pipeline: 2026.
   Cummings JL, Zhou Y, Yang Y, Zhong K, et al · · 2026 · PMID 42095064 · DOI 10.1002/trc2.70251
5. Small Molecule Therapeutics Targeting Amyloid-β in Alzheimer's Disease: Mechanisms, Clinical Progress, and Future Strategies.
   Park I, Lee D, Hong RS, Kim HY, et al · · 2026 · PMID 41906332 · DOI 10.5607/en25040
6. Pharmacokinetics of Novel Crystalline Buntanetap in Mice, Dogs, and Humans.
   Morin A, Christie M, Damiano E, Maccecchini ML. · · 2025 · PMID 41008606 · DOI 10.3390/biom15091299