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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04669028 | A Phase 3 Study of NE3107 in Probable Alzheimer's Disease | PHASE3 | COMPLETED | 439 | — | — | Aug 5, 2021 | Oct 25, 2023 | Nov 21, 2023 | 1 | United States |
| NCT05227820 | Insulin-Sensitizing Anti-Inflammatory Small Molecule for Investigative Treatment of Dementia | PHASE2 | COMPLETED | 23 | — | — | Jan 19, 2022 | Aug 20, 2022 | Jul 9, 2024 | 1 | United States |
test of 6 cognitive or functional domains, including memory, orientation, judgment, community affairs, home hobbies, and personal care are scored by certified raters after interviewing both participants and their informants. Higher score is indicative of more severe disease. The minimum score is 0 and the maximum score is 18. The CDR-SB is a co-primary outcome with ADAS-Cog12
The ADAS-Cog was developed to assess the level of cognitive dysfunction in Alzheimer's disease. It is also used in studies of interventions in people with mild cognitive impairment. It is also used for assessing the efficacy of antidementia treatments. The test is administered and scored by a certified rater to assess the cognitive domains of memory, language, orientation and praxis. A higher score is indicative of more severe disease, with 0 (no cognitive deficit) being the lowest score possible and 80 being the highest score and associated with severe cognitive impairment. ADAS-Cog12 is a co-primary outcome with CDR-SB.
Primary endpoints assessed changes from baseline in neurophysiological health and oxidative stress using advanced neuroimaging analyses. Analysis methods utilized blinded expert evaluation between baseline and completion scans.
| Arm | Type | Description |
|---|---|---|
| NE3107 | EXPERIMENTAL | Hard gelatin capsule containing 20 mg micronized NE3107 drug substance blended with common excipients for oral formulations |
| placebo | PLACEBO_COMPARATOR | Hard gelatin capsule containing only common excipients for oral formulations |
| Experimental Arm: NE3107 | EXPERIMENTAL | All participants will take 200mg BID (12 hours apart) of NE3107 for 3 months. |
| Name | Type | Description |
|---|---|---|
| NE3107 | DRUG | NE3107 is an investigational orally bioavailable, blood-brain barrier permeable anti-inflammatory agent with a new mechanism of action targeting multiple mechanisms of pathology in Alzheimer's disease. |
| Placebo | DRUG | capsules that do not contain NE3107 |
Inclusion Criteria: * 1\. Male or female subject aged 60 to 85 y at Screening (V1). 2. Has mild to moderate probable AD as defined by all of the following criteria: 1. Meets the National Institute on Aging and Alzheimer's Association (NIA-AA, 2011) criteria of all cause dementia and probable AD....