To Evaluate Effects of AZD1446, Placebo and Donepezil in Patients With 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate whether treatment with single and multiple oral doses of AZD1446 for 1 week will have effect on Quantified Electroencephalography and Event-Related Potentials in patients with Alzheimers Disease. The total treatment period is 9 weeks, divided into 5 equally long sub-periods of 7 days and 4 wash-out periods of 7 days each.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy, Safety, & Tolerability of AZD3480 Patients With Mild to Moderate Dementia of the Alzheimer's Type (AD)

NCT01466088

Alzheimer's Disease

COMPLETED PHASE2

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

NCT01039701

Mild to Moderate Alzheimer's Disease

COMPLETED PHASE2

A Brief Study To Evaluate The Safety, Tolerability, And Blood Levels Of Multiple Doses Of PF-044467943 Or Placebo In Combination With Donepezil In Subjects With Mild To Moderate Alzheimer's Disease

NCT00988598

Alzheimer's Disease

COMPLETED PHASE1

A Healthy Volunteer Study to Evaluate Reversibility of Induced Impairment of Cognition

NCT01044342

Cognition

COMPLETED PHASE1

BI 425809 in Patients With Cognitive Impairment Due to Alzheimer's Disease.

NCT02788513

Alzheimer Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer´s Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

2,5 mg once daily

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

Capsule, oral single and multiple dose

2

single dose of 5 mg

Group Type ACTIVE_COMPARATOR

Donepezil

Intervention Type DRUG

Capsule, oral and single dose

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule, oral and single dose

4

60 mg once daily

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

Capsule, oral single and multiple dose

5

60 mg three times daily

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

Capsule, oral single and multiple dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AZD1446

Capsule, oral single and multiple dose

Intervention Type DRUG

Donepezil

Capsule, oral and single dose

Intervention Type DRUG

Placebo

Capsule, oral and single dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of probable Alzheimer´s Disease
* Hachinski Ischaemic score \< 4
* MSE score 18 to 24

Exclusion Criteria

* History of any clinically significant disease or dementia other than Alzheimer´s Disease
* Current major depressive disorder or other major psychiatric disorders

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No