NCT03316898

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

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety, Tolerability, Pharmacokinetics, and Brain Metabolic Response, Using FDG-PET, Following Administration of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine) in Participants With Mild to Moderate Alzheimer's Disease

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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

• Alzheimer's Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-30
• Primary completion: 2018-11-04
• Completion: 2018-11-04
• First posted: 2017-10-20
• Last updated: 2018-11-02

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study