Alzheimer's Dementia (AD)Phase 2/3NCT07757204
An Open-label Long-term Safety Study of Buntanetap in Participants With AD
A Phase 2/3 study testing buntanetap/posiphen in people with Alzheimer's Dementia (AD), run by Annovis Bio Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer's Dementia (AD)
- What is being tested?
- buntanetap/posiphen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2026to May 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Stability of permitted medications for at least 4 weeks prior to screening.
- Adequate visual and hearing ability (physical ability to perform all assessments).
- Good general health with no disease expected to interfere with the study.
Who cannot join
- Has history of psychiatric disorder such as schizophrenia, bipolar disorder, or major depression according to the criteria of the most current version of the DSM, unless they are stable on treatment. Mild depression or history of depression that is stable on treatment with SSRI or SNRI at a stable dose is permitted.
- Has non-AD dementia, such as vascular dementia, Lewy Body dementia, frontotemporal dementia, Parkinson's disease dementia, B12 and thyroid deficiency cause dementia.
- History of seizure disorder, but if stable on medication is acceptable.
- ANVS-25001 legacy participants: screening MRI of brain indicative of significant abnormality, including but not limited to, prior hemorrhage (>5 microhemorrhages) or infarct >1cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g., abcess or brain tumor such as meningioma, unless they are documented and stable).
- Legacy participants from studies not ANVS-25001 submission of a historical MRI performed within the last year is encouraged for PI review. A screening MRI is not required.
- History or current evidence of long QT syndrome, Fridericia's formula corrected QT (QTcF) interval equal or greater than 450 ms for men and 460 ms for women, or torsades de pointes.
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- Has bradycardia (<50 bpm) or tachycardia (>100 bpm) on the ECG at screening.
- Has uncontrolled Type-1 or Type-2 diabetes. A participant with HbA1c levels up to 7.5% can be enrolled if the investigator believes the participant's diabetes is under control.
- Has clinically significang renal (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <45 mL/min/BSA (body surface area) or hepatic impairment (Alkaline phosphatase (ALP) > 2.0 ULN and/or total bilirubin > 2.0 ULN).
- Has any clinically significant abnormal laboratory values. Participants with liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than twice the upper limit of normal will be excluded.
- Is at imminent risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others in the opinion of the Investigators. Participants must be excluded if they report suicidal ideation with intent, with or without a plan or method (e. g., positive response to Items 4 or 5 in assessment of suicidal ideation on The Columbia Suicide Severity Rating Scale (C-SSRS)) in the past 2 months, or suicidal behavior in the past 6 months.
- Has cancer or has had a malignant tumor within the past year, except participants who underwent potentially curative therapy with no evidence of recurrence (participants with stable untreated cancer are not excluded).
- Alcohol / Substance use disorder, moderate to severe, in the last 5 years according to the most current version Diagnostic and Statistical Manual of Mental Disorders (DSM).
- Participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken.
- Participants with learning disability or developmental delay.
- Participants whom the site PI deems to be otherwise ineligible.
- Participants with a known allergy to the investigational drug or any of its components.
- Inactive ingredients of the investigational medicinal product:
- Silicified Microcrystalline Cellulose Dibasic Calcium Phosphate Dihydrate
- Mannitol
- Stearic Acid
- Hypromellosee (capsule shells structure)
- Titanium dioxide (opacifier of the capsule shells)
- Participant is currently pregnant, breast-feeding, and/or lactating.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Alzheimer's Disease
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.
Read the detailed description
ANVS-26001 will be a 24-month open-label safety study. Qualified participants will receive buntanetap 30 mg daily after a screening period of up to 42 days. ADAS-Cog13, ADCS-iADL, CDR, MMSE, WAIS-Coding, NPI-12, QoL-AD, CGI-S, and C-SSRS will be assessed by clinicians who have successfully completed the requisite certifications/trainings for each assessment. Each participant shall be assessed by the same clinician throughout the study. An independent Data and Safety Monitoring Board (DSMB) will assess treatment safety.
- Conditions
- Alzheimer's Dementia (AD)
- Being tested
- buntanetap/posiphen
- Keywords
- Alzheimer's Dementia, buntanetap, posiphen, Annovis Bio, Open-Label Extension
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
buntanetap/posiphenDrug
buntanetap 30 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All participants receive buntanetap 30 mg qd Receives: Drug: buntanetap/posiphen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of buntanetap
Safety assessments of participants with AD receiving treatment with buntanetap
Measured: 24 months of treatment
Adverse Events (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention
Measured: 24 months of study
Treatment Emergent Adverse Events (TEAE)
TEAE is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state
Measured: 24 months of study
Serious Adverse Events (SAE)
SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization, or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a birth defect or congenital anomaly
Measured: 24 months of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start21 Sep 2026 (estimated)
- Primary completion21 Feb 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Dementia (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Annovis Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757204
- Sponsor's protocol ID
- ANVS-26001
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Clinical Trial Investigating the Long-term Safety of Buntanetap in Treating Participants With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07757204
- Acronym / sponsor ID
- ANVS-26001
- Conditions
- Alzheimer's Dementia (AD)
- Keywords
- Alzheimer's Dementia, buntanetap, posiphen, Annovis Bio, Open-Label Extension
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Annovis Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 21 Feb 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ANVS-26001 will be a 24-month open-label safety study. Qualified participants will receive buntanetap 30 mg daily after a screening period of up to 42 days. ADAS-Cog13, ADCS-iADL, CDR, MMSE, WAIS-Coding, NPI-12, QoL-AD, CGI-S, and C-SSRS will be assessed by clinicians who have successfully completed the requisite certifications/trainings for each assessment. Each participant shall be assessed by the same clinician throughout the study. An independent Data and Safety Monitoring Board (DSMB) will assess treatment safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: buntanetap/posiphenAll participants receive buntanetap 30 mg qd |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (25 listed)
- Has history of psychiatric disorder such as schizophrenia, bipolar disorder, or major depression according to the criteria of the most current version of the DSM, unless they are stable on treatment. Mild depression or history of depression that is stable on treatment with SSRI or SNRI at a stable dose is permitted.
- Has non-AD dementia, such as vascular dementia, Lewy Body dementia, frontotemporal dementia, Parkinson's disease dementia, B12 and thyroid deficiency cause dementia.
- History of seizure disorder, but if stable on medication is acceptable.
- ANVS-25001 legacy participants: screening MRI of brain indicative of significant abnormality, including but not limited to, prior hemorrhage (>5 microhemorrhages) or infarct >1cm3, >3 lacunar infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g., abcess or brain tumor such as meningioma, unless they are documented and stable).
- Legacy participants from studies not ANVS-25001 submission of a historical MRI performed within the last year is encouraged for PI review. A screening MRI is not required.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| buntanetap/posiphenbuntanetap 30 mg daily | Drug | Single Arm |
Primary outcome
Safety of buntanetap
Time frame: 24 months of treatment
Safety assessments of participants with AD receiving treatment with buntanetap
Adverse Events (AE)
Time frame: 24 months of study
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention
Treatment Emergent Adverse Events (TEAE)
Time frame: 24 months of study
TEAE is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state
Serious Adverse Events (SAE)
Time frame: 24 months of study
SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization, or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a birth defect or congenital anomaly
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing buntanetap/posiphen in people with Alzheimer's Dementia (AD), run by Annovis Bio Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah MacCallum, BSN RN (484-875-3192, maccallum@annovisbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of buntanetap (time frame: 24 months of treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.