To Evaluate Effects of AZD1446, Placebo and Donepezil in Patients With Alzheimer's Disease

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Alzheimer´s Disease

Treatments: Drug: Placebo; Drug: Donepezil; Drug: AZD1446

Study type: Interventional

Funder types: Industry

Identifiers

NCT01125683

D1950C00011

2010-018273-38 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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40 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

2,5 mg once daily

Treatment:

Drug: AZD1446

2

Active Comparator group

Description:

single dose of 5 mg

Treatment:

Drug: Donepezil

3

Placebo Comparator group

Treatment:

Drug: Placebo

4

Experimental group

Description:

60 mg once daily

Treatment:

Drug: AZD1446

5

Experimental group

Description:

60 mg three times daily

Treatment:

Drug: AZD1446