Approval Probability
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buntanetap/posiphen · 5 trials · 6 indications
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.
Change in the Score from the MDS- Unified Parkinson's Disease Rating Scale (UPDRS) Parts II from Baseline to the End of Trial. MDS-UPDRS Part II (Motor experiences of daily living) has 13 items and the score ranges from 0-52, with higher scores reflecting greater severity.
Safety assessments of participants with AD receiving treatment with buntanetap
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
TEAE is an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state
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
Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) measures cognitive functions and non-cognitive functions such as mood and behavior. It was designed to measure the cognitive and behavioral domains known to be affected in Alzheimer disease, including memory, language, orientation, construction, and planning of simple designs, and completed simple goal-oriented behaviors. Specifically, the ADAS-Cog comprises ratings from 11 components: word recall, word recognition, constructional praxis, orientation, naming objects and fingers, commands, ideational praxis, remembering test instructions, spoken language, word finding, and comprehension. Total scores range from 0-70, with higher scores indicating greater cognitive impairment.
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of informants. The ADCS-CGIC measures whether the effects of active treatment are substantial enough to be detected by a skilled and experienced clinician on the basis of a clinical interview and examination. It relies on both direct examination of the patient and an interview of the study partner. A skilled and experienced clinician who is blinded to treatment assignment rates the patient on a 7-point Likert scale, ranging from 1 (marked improvement) to 7 (marked worsening). Lower scores indicate better improvement.
| Arm | Type | Description |
|---|---|---|
| buntanetap | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| 10 mg buntanetap/posiphen | EXPERIMENTAL | Buntanetap/posiphen 10 mg oral capsule with daily administration for a period of 6 months |
| 20 mg buntanetap/posiphen | EXPERIMENTAL | Buntanetap/posiphen 20 mg oral capsule with daily administration for a period of 6 months |
| Single Arm | EXPERIMENTAL | All participants receive buntanetap 30 mg qd |
| Cohort 1 - buntanetap | EXPERIMENTAL | Cohort 1 will enroll via invitation only for PD participants who have previously participated in bun |
| Cohort 2 - buntanetap | EXPERIMENTAL | Cohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment. |
| 7.5mg Buntanetap/Posiphen | EXPERIMENTAL | Buntanetap/Posiphen 7.5mg oral capsule with daily administration for a period of 12 weeks |
| 15mg Buntanetap/Posiphen | EXPERIMENTAL | Buntanetap/Posiphen 15mg oral capsule with daily administration for a period of 12 weeks |
| 30mg Buntanetap/Posiphen | EXPERIMENTAL | Buntanetap/Posiphen 30mg oral capsule with daily administration for a period of 12 weeks |
| 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. ...
Buntanetap is an investigational small molecule being studied for the treatment of early Alzheimer's disease, mild to moderate Alzheimer's disease, and Parkinson's disease. It is being evaluated in clinical trials for its potential to address these neurological conditions.
Buntanetap is being developed by Annovis Bio, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ANVS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Alzheimer's and Parkinson's disease.
Buntanetap is in Phase 2 and Phase 3 clinical development. It has completed Phase 2 and Phase 3 trials in Parkinson's disease and Alzheimer's disease, and additional Phase 2 and Phase 3 trials are currently active or recruiting participants.
Buntanetap is being studied in several clinical trials, including NCT05357989, a completed Phase 3 trial in early Parkinson's disease; NCT05686044, a completed Phase 2 trial in mild to moderate Alzheimer's disease; NCT06709014, an active Phase 3 trial in early Alzheimer's disease; and NCT07284784, a recruiting Phase 2 trial in Parkinson's disease.
Yes, Buntanetap is also known as Posiphen. The drug is referred to by both names in clinical research and development contexts, and it is being investigated for the same neurological indications under both names.
Buntanetap is a small molecule designed to target the underlying pathology of neurodegenerative diseases. It is being studied for its ability to reduce the production of toxic proteins associated with Alzheimer's and Parkinson's disease, potentially slowing disease progression.