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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Mild to Moderate Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

AZD1446 60mg once daily + donepezil 10mg

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

capsules, oral, 3 times daily

2

AZD1446 60mg three times daily + donepezil 10mg

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

capsules, oral, 3 times daily

3

AZD1446 30mg three times daily + donepezil 10mg

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

capsules, oral, 3 times daily

4

placebo + donepezil 10mg

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

capsules, oral, 3 times daily, 4 weeks

Interventions

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AZD1446

capsules, oral, 3 times daily

Intervention Type DRUG

Placebo

capsules, oral, 3 times daily, 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No