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NCT03486938 · ClinicalTrials.gov registry record · Phase 2
Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease
A Phase 2 study of Mild Cognitive Impairment and Prodromal Alzheimer's Disease, sponsored by AgeneBio.
- Completed
- Registry status
- Phase 2
- Development phase
- 164
- Enrollment target
- 20
- Study locations
NCT03486938: Completed Phase 2 study of Mild Cognitive Impairment and Prodromal Alzheimer's Disease, sponsored by AgeneBio.
NCT03486938 is a Phase 2 study of Mild Cognitive Impairment and Prodromal Alzheimer's Disease that has completed, run by AgeneBio. The registered enrollment target is 164 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03486938, a Phase 2 study of Mild Cognitive Impairment and Prodromal Alzheimer's Disease, has completed, sponsored by AgeneBio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 164 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study is to evaluate the efficacy of AGB101 on slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with mild cognitive impairment due to Alzheimer's Disease (MCI due to AD) also known as prodromal AD. Participants will be randomized to receive placebo or AGB101 (220 mg), once daily for 78 weeks. Secondary objectives are to assess the effect of AGB101 compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE) and Functional Activities Questionnaire (FAQ).
Primary Outcome
CDR-SB scores at baseline were subtracted from CDR-SB scores at week 78 to generate the change score from baseline, with a possible total range of -18 to 18. Positive change scores reflect greater impairment on the CDR-SB at week 78, while negative change scores reflect less impairment on the CDR-SB at week 78.
Conditions Studied
Interventions
- DRUG Placebo Oral Tablet
- DRUG AGB101 220 mg tablet
Study Locations (20)
Florida
- Boynton Beach Medical Research Institite - Boynton Beach
- Brain Matters Research - Delray Beach
- MD Clinical - Hallandale
- Miami Jewish Health - Miami
- Bioclinica Research - Orlando
- IMIC Research - Palmetto Bay
- The Roskamp Institute, Inc - Sarasota
- Brain Matters Research - Stuart
New Jersey
- The NeuroCognitive Institute - Mount Arlington
- Global Medical Institutes LLC; Princeton Medical Institute - Princeton
- Neurology Specialist of Monmouth County, PA - West Long Branch
California
- Senior Clinical Trials, Inc. - Laguna Hills
- Excell Research Inc - Oceanside
Arizona
- Banner Alzheimer's Institute - Phoenix
Colorado
- The Mile High Research Center - Denver
Georgia
- NeuroStudies.net, LLC - Decatur
Illinois
- Great Lakes Clinical Trials - Chicago
Maryland
- Johns Hopkins University School of Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2018-12-13 |
| Est. Completion | 2022-11-02 |
| Phase | Phase 2 |
What the finished NCT03486938 record still lists
NCT03486938 is an interventional study that assigns participants to a tested intervention. The registered 164 participants enrollment target is mid-sized for trials with a published cap, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT03486938 names 20 study sites across 10 states, led by Florida, New Jersey, California.
Frequently Asked Questions
What is clinical trial NCT03486938 about?
NCT03486938 is a clinical study titled "Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease". The primary objective of the study is to evaluate the efficacy of AGB101 on slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with mild cognitive impairment due to Alzheimer's Diseas...
What is the current status of trial NCT03486938?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 164 participants. The study started on 2018-12-13. Estimated completion is 2022-11-02.
What conditions does trial NCT03486938 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Prodromal Alzheimer's Disease.
What interventions are being tested in trial NCT03486938?
The interventions under investigation include: Placebo Oral Tablet (DRUG), AGB101 220 mg tablet (DRUG).
Who is sponsoring clinical trial NCT03486938?
This trial is sponsored by AgeneBio, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03486938 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03486938's enrollment target sits among peer trials
164 61st of 205 higher than 145 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Cognitive Impairment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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