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Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease

NCT03486938 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2024-05-17

Study results available
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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

Interventions

DRUG

Placebo Oral Tablet

Placebo oral tablet

DRUG

AGB101 220 mg tablet

220 mg AGB101 active compound

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • AgeneBio

    lead INDUSTRY

Principal Investigators

  • Richard Mohs, PhD · AgeneBio

  • Sharon Rosenzweig-Lipson, PhD · AgeneBio

  • Russell Barton, MS · AgeneBio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-13
Primary Completion
2022-11-02
Completion
2022-11-02
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03486938 on ClinicalTrials.gov