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← Trials/Trial dossier/NCT00191009

CompletedPhase 2 / PHASE3

Adding Atomoxetine To Standard Medication Treatment In Patients With Alzheimer's Disease

Atomoxetine Augmentation of Cholinesterase Inhibitor Therapy in Patients With Alzheimer's Disease

Asset

Atomoxetine

Listed sites

3

Recruiting sites

-

Enrollment

124

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•To see if Alzheimer's patients receiving a stable dose of an Alzheimer's drug

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 ID7951
SecondaryB4Z-MC-LYCG
NCT IDNCT00191009

Timeline

Milestones

Study start2003-10 (month precision)
Study first posted2005-09-19estimated
Study completion2006-01actual (month precision)
Last update posted2007-11-06estimated

Assets

Drug assets

Atomoxetine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Patient presents with Alzheimer's Disease based on clinical history.
•Patient must have a Mini Mental Status Score between 10 and 26.
•Patient must have a reliable caregiver in frequent or daily contact with the patient.
•Patient must be currently treated with and on a stable dose of a standard Alzheimer's drug treatment for at least 3 months

Exclusion criteria

•Patients who are receiving pharmacologic treatments (other than a cholinesterase inhibitor or memantine) for Alzheimer's Disease.
•Patients who have a history in the past 5 years or any current evidence of major psychiatric illness.
•Patients who have narrow angle glaucoma.
•Patients who are experiencing clinically significant urinary hesitancy or retention as assessed by a physician.

Endpoints (5)

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

Global cognition
2
Behavior / neuropsychiatric
1
Other clinical outcomes
1
Other (unclassified)
1

Global cognition

2 endpoints
Primary/protocol endpoint

To see if Alzheimer's patients receiving a stable dose of an Alzheimer's drug randomly assigned to atomoxetine for approximately 6 months will have cognitive performance improved as measured by the Alzheimer's Disease Assessment Scale - Cognitive

descriptive

Secondary/protocol endpoint

To see if current Alzheimer's medications plus atomoxetine compared to Alzheimer's medications plus placebo is better at preserving or slowing cognitive decline as measured by the Alzheimer's Disease Cooperative Study Inventory - Activities of

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

To see if patients taking an Alzheimer's medication plus atomoxetine will display less comorbid psychological symptoms, such as depression, as assessed by the Neuropsychiatric Inventory (NPI). Patients will receive the NPI once before randomization

Neuropsychiatric Inventory (NPI)

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

To see if patients taking an Alzheimer's medication plus atomoxetine for approximately 6 months will be superior to an Alzheimer's medication alone as assessed by the Clinician's Interview-Based Impression of Change (CIBIC+) score.

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

To show that current Alzheimer's drugs can be taken with atomoxetine without significant side effects.

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.