Phase 2
N=23
Insulin-Sensitizing Anti-Inflammatory Small Molecule for Investigative Treatment of Dementia
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT05227820 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change in fMRI — 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NE3107 (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Neurological Associates of West Los Angeles
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in fMRI |
11 | — |
| SECONDARY Clinical Dementia Rating Change as Calculated From the Quick Dementia Rating Scale Change |
14 | — |
| SECONDARY Montreal Cognitive Assessment (MoCA) Change |
9 | — |
| SECONDARY Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Change |
13 | — |
| SECONDARY Mini-Mental State Examination (MMSE) Change |
8 | — |
Summary
This study seeks to measure changes in cognition through verbal and visual test procedures and changes in biomarkers of Alzheimer's disease and inflammatory and metabolic parameters that can be measure in the central nervous system (CNS) with advanced neuroimaging techniques in patients treated with NE3107 (17a-ethynyl-androst-5-3b,7b,17b-triol).
Eligibility Criteria
In order for a subject to be considered for this study, the following criterion is required:
Inclusion Criteria
- Cognitive decline with Clinical Dementia Rating (CDR) score of 0.5 to 1, suggesting mild cognitive impairment to mild dementia.
- Participants must be between the ages of 50-89
- Primary cognitive complaint must be memory Impairment without movement or psychiatric explanation/diagnosis
- Participants must show at least one abnormal imaging biomarker and none of the exclusion criteria below.
Exclusion Criteria
In order for a subject to be considered for this study, he/she may NOT have any of the following:
- Subjects with contraindications for lumbar puncture, such as bleeding abnormalities, use of anticoagulant medications, and local skin or spine abnormalities
- Reversible causes of cognitive impairment that explains the clinical status entirely, such as hypothyroidism, depression
- Advanced stages of any terminal illness or any active cancer that requires chemotherapy
- History of breast cancer
- Women with child-bearing potential who are not willing to use a double-barrier birth control method
- Males not willing to use a double-barrier birth control method with female sex partners with child-bearing potential
Data sourced from ClinicalTrials.gov (NCT05227820). 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.