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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01039701

Acronym

ROBIN

Enrollment

Registered

2009-12-25

Start date

2009-12-31

Completion date

2010-07-31

Last updated

2010-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to Moderate Alzheimer's Disease

Keywords

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

Brief summary

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.

Interventions

DRUGAZD1446

capsules, oral, 3 times daily

DRUGPlacebo

capsules, oral, 3 times daily, 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

60 Years to 85 Years

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Czechia, Hungary, Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026