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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Mild to Moderate Alzheimer's Disease

Treatments: Drug: Placebo; Drug: AZD1446

Study type: Interventional

Funder types: Industry

Identifiers

NCT01039701

D1950C00006

Details and patient eligibility

About

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.

Enrollment: 99 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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99 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

AZD1446 60mg once daily + donepezil 10mg

Treatment:

Drug: AZD1446

2

Experimental group

Description:

AZD1446 60mg three times daily + donepezil 10mg

Treatment:

Drug: AZD1446

3

Experimental group

Description:

AZD1446 30mg three times daily + donepezil 10mg

Treatment:

Drug: AZD1446

4

Placebo Comparator group

Description:

placebo + donepezil 10mg

Treatment:

Drug: Placebo