4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease

Phase 2

Completed

• Conditions: Mild to Moderate Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: AZD1446

• Registration Number: NCT01039701
• Lead Sponsor: AstraZeneca

Brief Summary

The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to moderate Alzheimer's disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-20
• Study First Submitted QC: 2009-12-24
• Study First Posted: 2009-12-25
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-10
• Last Update Posted: 2010-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• history of progressive worsening of memory and other cognitive functions for at least 12 months
• treatment with stable dose of donepezil (10 mg) for at least 3 months
• the patient should have an appropriate caregiver, who is required for all study visits

Exclusion Criteria

• history of allergy/hypersensitivity reactions
• significant neurological disease or dementia other than Alzheimer's disease
• myocardial infarction or acute coronary syndrome within the last year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	Placebo	placebo + donepezil 10mg
1	AZD1446	AZD1446 60mg once daily + donepezil 10mg
2	AZD1446	AZD1446 60mg three times daily + donepezil 10mg
3	AZD1446	AZD1446 30mg three times daily + donepezil 10mg

Primary Outcome Measures

Name	Time	Method
Nature and incidence of adverse events	From the enrollment visit until the last study follow-up visit. The measure will be taken at each scheduled study visit and in between visits , if any adverse events occur.

Secondary Outcome Measures

Name	Time	Method
To evaluate any effects PK of AZD1446 as an add-on treatment to donepezil on the PK of donepezil	Twice during the study: at Visit 2 and Visit 10.
To characterize the PK of AZD1446 as an add-on treatment to donepezil in AD patients	Twice during the study: at Visit 8 and Visit 10.
To explore the effects of 3 dose regimens of AZD1446 compared to placebo as an add-on treatment to donepezil on changes in global functioning using ADCS-CGIC	Baseline assessment at Visit 2 and a follow-up assessment at Visit 10

Trial Locations

Locations (1)

Research Site; 🇸🇰 Zlate Moravce, Slovakia