ROBIN

CompletedPhase 2

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

Lead sponsor

AstraZeneca

Asset

AZD1446

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Study partner/caregiver required•AD symptomatic therapy: stable ≥3 months

Primary endpoint

•Nature and incidence of adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDD1950C00006

NCT IDNCT01039701

Timeline

Milestones

Study start2009-12 (month precision)

Study first posted2009-12-25estimated

Primary completion2010-07actual (month precision)

Study completion2010-07actual (month precision)

Last update posted2010-08-11estimated

Assets

Drug assets

AZD1446

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Nature and incidence of adverse events

Time frame: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.

event count, event

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

To evaluate any effects PK of AZD1446 as an add-on treatment to donepezil on the PK of donepezil

Time frame:Twice during the study: at Visit 2 and Visit 10.

descriptive

Secondary/protocol endpoint/low confidence

To characterize the PK of AZD1446 as an add-on treatment to donepezil in AD patients

Time frame:Twice during the study: at Visit 8 and Visit 10.

descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline assessment at Visit 2 and a follow-up assessment at Visit 10

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.