Phase 3
N=351
A Dose-ranging Study to Investigate Efficacy of Buntanetap in Mild to Moderate AD
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT05686044 ↗Enrolled (actual)
351
Serious AEs
1.7%
Results posted
Apr 2025
Primary outcome: Primary: Change From Baseline to Week 12 in ADAS-Cog11 — -2.32; -1.34; -3.01; -2.24 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Buntanetap/Posiphen (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Annovis Bio Inc.
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 in ADAS-Cog11 |
-2.32; -1.34; -3.01; -2.24 | — |
| PRIMARY ADCS-CGIC at Week 12 |
3.58; 3.96; 3.61; 3.83 | — |
| SECONDARY Change From Baseline to Week 12 in ADCS-ADL |
2.03; -0.14; 1.71; 0.15 | — |
Summary
The purpose of this study is to measure efficacy and safety of three different doses of buntanetap/Posiphen compared with placebo in participants with mild to moderate Alzheimer's disease.
Study details include:
The double-blind treatment duration will include a screening period of up to 42 days followed by 12 weeks of treatment at home.
The study duration will be 4-5 months. There will be 4 in-clinic visits and 1 phone call.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Alzheimer's disease according to National Institute on Aging and National Institute on Aging and Alzheimer's Association criteria for probable AD
- Male or female aged 55 - 85 years.
- MMSE 14-24.
- Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week) and will accompany the participant to study visits at designated times.
- Female participants of childbearing potential* must have a negative urine pregnancy test at Screening, must be non-lactating and must agree to use a highly effective method of contraception (i.e., a method resulting in a failure rate of less than 1% per year when used consistently and correctly) during the trial and for 4 weeks after the last dose of trial treatment, 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
- 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, and the absence of sperm has been confirmed. 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 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.
- 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 subject 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
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Participants can provide written informed consent. If PI deems that participant cannot fully understand the consent form to give consent, their legally authorized representative (LARs) can provide written informed consent. Participants can comply with scheduled visits, and other study-related procedures to complete the study with the help of the study partner.
- No evidence of current suicidal ideation or previous suicide attempt in the past 2 months as evaluated in the Columbia Suicide Severity Rating Scale nor suicidal behavior in the past 6 months as per investigator.
- Stability of permitted medications for at least 4 weeks prior to screening.
- Cholinesterase inhibitors and/or memantine medication
- Anticonvulsant medications used for epilepsy or mood stabilization, neuropathic pain indications.
- Mood-stabilizing psychotropic agents, including, but not limited to, lithium.
- Adequate visual and hearing ability (physical ability to perform all the study assessments) as per investigator.
- Good general health with no disease expected to interfere with the study as per investigator.
Exclusion Criteria
- Has a history of a psychiatric disorder such as schizophrenia, bipolar disorder or major depression a
Data sourced from ClinicalTrials.gov (NCT05686044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.