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A FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine) for the Treatment of Participants With Mild to Moderate Alzheimer's Disease

NCT03316898 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-11-02

No results posted yet for this study

Summary

This is a study to evaluate the brain metabolic response using Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), safety, tolerability and pharmacokinetics of AGN-242071 in patients with mild to moderate Alzheimer's Disease on a stable dose of 10 mg donepezil with or without memantine standard of care.

Conditions

Interventions

DRUG

AGN-242071

AGN-242071 capsules administered once daily to patients receiving donepezil 10 mg with or without memantine as prescribed per standard of care.

DRUG

Placebo

Placebo capsules once daily to patients receiving donepezil 10 mg with or without memantine as prescribed per standard of care.

DRUG

Donepezil

Donepezil 10 mg as prescribed by the physician as per standard of care.

DRUG

Memantine

Memantine as prescribed by the physician as per standard of care.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Mitalee Tamhane, PhD · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2018-11-04
Completion
2018-11-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT03316898 on ClinicalTrials.gov