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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 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.

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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).

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

FieldValue
Enrollment Target 164 participants
Start Date 2018-12-13
Est. Completion 2022-11-02
Phase Phase 2

Sponsor

AgeneBio

1 total trials

What the Registry Record Tells You About NCT03486938

The ClinicalTrials.gov registry entry for NCT03486938 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (87% lower). The listed sponsor is AgeneBio, which has 1 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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