NCT06709014
A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD
Active, Not Recruiting
PHASE3Ages 55–85InterventionalTreatmentAnnovis Bio Inc.
~760 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:buntanetap/posiphenPlacebo
At a glance
Recruiting sites
0 of 78 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13)
Measured over From screening to 6-month readout, to end of treatment at 18 months.
+1 more outcome measured
Conditions
Where it's being run
78 sites across 29 statesFlorida19
California6
New York6
Illinois5
Massachusetts4
Texas4
Arizona3
Ohio3
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Exclusion
Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation,
Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation,
Intrauterine device (IUD),
Intrauterine hormone-releasing system (IUS),
Bilateral tubal occlusion,
Vasectomized partner (a vasectomized partner is a highly effective contraception method provided that the partner is the sole male sexual partner of the participant. If not, an additional highly effective method of contraception should be used),
Sexual abstinence (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant).
Non-childbearing potential includes surgically sterilized or postmenopausal with no menstrual bleeding for at least one year prior to study start. 9. Male participants must be sterile or sexually inactive or agree not to father a child during the study and one month after the last dose of study medication and must agree to use a barrier method for contraception. Female partners of male participants must adopt a highly effective method of contraception with a failure rate of less than 1% per year when used consistently and correctly such as:
Oral, intravaginal, or transdermal combined (estrogen plus progestogen) hormonal contraception associated with inhibition of ovulation,
Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation,
IUD,
IUS,
Bilateral tubal occlusion. 10. General cognition and functional performance sufficiently preserved that the subject can provide written informed consent. At re-consent, a legally authorized representative may co-sign if participants do not meet the general cognition and functional performance needed in the opinion of the investigator. 11. No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the Columbia Suicide Severity Rating Scale. 12. Stability of permitted medications for at least 4 weeks prior to screening. Refer to Concomitant Medications section for details on prohibited and permitted medications.
Cholinesterase inhibitors and/or memantine medication,
Anticonvulsant medications used for epilepsy or mood stabilization, or neuropathic pain indications, and have not had a breakthrough seizure in 3 years prior to screening
Mood-stabilizing psychotropic agents including, but not limited to, lithium. 13. Adequate visual and hearing ability (physical ability to perform all the study assessments). 14. Participants previously exposed to buntanetap can still be included in the study after a 28-day wash out period.
Silicified Microcrystalline Cellulose
Dibasic Calcium Phosphate Dihydrate
Mannitol
Stearic Acid
Hypromellosee (capsule shells structure)
Titanium dioxide (opacifier of the capsule shells) 17. Participant is currently pregnant, breast-feeding, and/or lactating. 18. Participant is currently taking strong and moderate CYP3A4 inhibitors and/or inducers. Refer to Concomitant Medications section below for details on prohibited and permitted medications. 19. Participants with uncontrolled hypertension (systolic \>160mm Hg and/or diastolic \>95mm Hg) or hypotension (systolic \<90mm Hg and/or diastolic \<60 mm Hg) and deemed medically significant by the PI.
What this trial measures
- Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog13)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)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, including activities such as shopping, maintaining appointments, or managing one's belongings or finances. The ADCS-iADL subset is assessed with items 6a and 7-23; scores range from 0 to 59, with lower scores indicating greater impairment in function.