Trial intelligence / Profile preview

AZD3480 vs Donepezil in Mild to Moderate Alzheimer's Disease

NCT01466088Phase 2

Key facts

Status: Completed
Start: Oct 2011
Primary completion: May 2014
Countries: 5
Sponsor: Targacept
Modality: Small Molecules

Drugs: ispronicline
Conditions: Alzheimer's disease (AD)

Overview

Phase 2, randomised, double-blind trial of ispronicline in Alzheimer's disease (AD) (2 arms), sponsored by Targacept. Primary endpoints: Alzheimer's Disease Assessment Scale-cognitive subscale at 52 weeks, Clinician Interview-Based Impression of Change plus carer interview at 52 weeks and 1 more. Started Oct 2011; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

AZD3480
AZD3480 30 mg daily
Donepezil
Donepezil 5-10 mg daily

Who it enrols

Patients with mild to moderate Alzheimer's disease (MMSE 12-22) and a caregiver, excluding those with vascular dementia, other dementias, or recent use of psychotropic medications.

Endpoints

Primary

Alzheimer's Disease Assessment Scale-cognitive subscale52 weeks
Clinician Interview-Based Impression of Change plus carer interview52 weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living52 weeks

Secondary

Neuropsychiatric Inventory52 weeks
Mini-Mental State Examination52 weeks
Alzheimer's Disease Related Quality of Life52 weeks

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