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

Study Overview
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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.

Official Title
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Safety, Tolerability and Pharmacokinetics of 3 Dose Regimens of AZD1446 vs. Placebo as an Add-on Treatment to Donepezil: A Multi-centre, Double-blind, Randomised, Placebo Controlled, Parallel Group Phase IIa Study in Patients With Mild to Moderate Alzheimer's Disease During 4 Weeks of Treatment

Conditions
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Mild to Moderate Alzheimer's Disease

Intervention / Treatment
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* Drug: AZD1446
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD1446 60mg once daily + donepezil 10mg | Drug: AZD1446<br>* capsules, oral, 3 times daily<br>|
| Experimental: 2<br>AZD1446 60mg three times daily + donepezil 10mg | Drug: AZD1446<br>* capsules, oral, 3 times daily<br>|
| Experimental: 3<br>AZD1446 30mg three times daily + donepezil 10mg | Drug: AZD1446<br>* capsules, oral, 3 times daily<br>|
| Placebo Comparator: 4<br>placebo + donepezil 10mg | Drug: Placebo<br>* capsules, oral, 3 times daily, 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, tolerability, mild to moderate Alzheimer's disease, To determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil in patients with mild to moderate Alzheimer's disease