Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06709014 | A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants With Early AD | PHASE3 | ACTIVE NOT_RECRUITING | 760 | — | — | Feb 4, 2025 | Jun 1, 2028 | May 18, 2026 | 78 | United States |
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.
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.
| Arm | Type | Description |
|---|---|---|
| buntanetap | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| buntanetap/posiphen | DRUG | 30mg capsule by mouth once daily for 18 months |
| Placebo | DRUG | Placebo capsule by mouth once daily for 18 months |
Inclusion Criteria: 1. Diagnosis of AD according to the 2024 National Institute on Aging and Alzheimer's Association criteria. 2. Male or female, aged 55 - 85 years. 3. MMSE 20-28 at screening and baseline. 4. CDR global score=0.5 or 1, with memory box score at least 0.5 at screening and baseline. ...