Not Yet RecruitingPhase 2/3

An Open-label Long-term Safety Study of Buntanetap in Participants With AD

400 participantsStarted 2026-09-21

Plain-language summary

This study will examine the long-term safety of buntanetap in participants with AD who have participated in a prior study of buntanetap in AD.

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Has participated in a prior Alzheimer's clinical trial with buntanetap.
. Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (minimum 10 hours per week), and will accompany the participant on study visits at designated times.
. Female participants of childbearing potential must have a negative urine pregnancy test at screening, be non-lactating, and must agree to use a highly effective method of contraception.
. 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.
. General cognition and functional performance sufficiently preserved that the subject can provide written informed consent. Legally authorized representatives will be needed for participants whose MMSE is equal or less than 20 at screening.
. No evidence of current suicidal ideation or previous suicide attempt in the last month as evaluated in the CSSRS.
. Stability of permitted medications for at least 4 weeks prior to screening.
. Adequate visual and hearing ability (physical ability to perform all assessments).

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety of buntanetap

Timeframe: 24 months of treatment

Adverse Events (AE)

Timeframe: 24 months of study

Treatment Emergent Adverse Events (TEAE)

Timeframe: 24 months of study

Serious Adverse Events (SAE)

Timeframe: 24 months of study

Trial details

NCT IDNCT07757204

SponsorAnnovis Bio Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-02-21

Contact for this trial

Sarah MacCallum, BSN RN

484-875-3192 maccallum@annovisbio.com

View on ClinicalTrials.gov More Alzheimer's Dementia (AD) trials

Who can participate

Age range

55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Has participated in a prior Alzheimer's clinical trial with buntanetap.
. Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (minimum 10 hours per week), and will accompany the participant on study visits at designated times.
. Female participants of childbearing potential must have a negative urine pregnancy test at screening, be non-lactating, and must agree to use a highly effective method of contraception.
. 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.
. General cognition and functional performance sufficiently preserved that the subject can provide written informed consent. Legally authorized representatives will be needed for participants whose MMSE is equal or less than 20 at screening.
. No evidence of current suicidal ideation or previous suicide attempt in the last month as evaluated in the CSSRS.
. Stability of permitted medications for at least 4 weeks prior to screening.
. Adequate visual and hearing ability (physical ability to perform all assessments).