Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease
NCT03486938 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03486938
The ClinicalTrials.gov registry entry for NCT03486938 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AgeneBio, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03486938 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, New Jersey, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03486938?
The interventions under investigation include: Placebo Oral Tablet (DRUG), AGB101 220 mg tablet (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03486938?
This trial is sponsored by AgeneBio, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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