A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD (NCT06709014) | Clinical Trial Compass
RecruitingPhase 3
A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD
United States760 participantsStarted 2025-02-04
Plain-language summary
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
Who can participate
Age range55 Years – 85 Years
SexALL
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Inclusion criteria
✓. Diagnosis of AD according to the 2024 National Institute on Aging and Alzheimer's Association criteria.
✓. Male or female, aged 55 - 85 years.
✓. MMSE 20-28 at screening and baseline.
✓. CDR global score=0.5 or 1, with memory box score at least 0.5 at screening and baseline.
✓. Positive for amyloid beta as defined by plasma p-tau217 level at screening.
Exclusion criteria
✕. 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 on 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 one month after the last dose of trial treatment, such as:
. 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:
✕0. 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.
✕1. No evidence of current suicidal ideation or previous suicide attempt in the past month as evaluated in the Columbia Suicide Severity Rating Scale.
✕2. Stability of permitted medications for at least 4 weeks prior to screening. Refer to Concomitant Medications section for details on prohibited and permitted medications.
✕3. Adequate visual and hearing ability (physical ability to perform all the study assessments).
✕4. Participants previously exposed to buntanetap can still be included in the study after a 28-day wash out period.