Effects of Atomoxetine in Mild Cognitive Impairment
Effects of Atomoxetine in Mild Cognitive Impairment
Overall Status:
Recruiting
Brief Description:
The purpose of this Phase II study is to find out if the drug atomoxetine causes a change in the biomarkers (substances that may indicate the presence of a disease) in the cerebrospinal fluid (CSF) of people diagnosed with mild cognitive impairment (MCI).
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | 90 Years | Both | No |
Inclusion Criteria:
- Good general health, with general cognition and functional performance preserved
- Subjective memory concern per subject, study partner, or clinician
- Diagnosis of amnestic MCI (single or multi-domain)
- Abnormal memory per Logical Memory subscale from Wechsler Memory Scale-Revised; Clinical Dementia Rating = 0.5; Memory Box score of at least 0.5; Mini Mental State Exam score of 24-30 (exceptions considered for less than 8 year of education)
- Cholinesterase inhibitors and memantine allowed if stable for at least 12 weeks
- Study partner who has regular contact with subject, can provide reliable assessment of subject's level of function, and can attend all visits
- Hearing and seeing ability adequate for testing
- Women of child-bearing potential willing to use medically acceptable birth control or practice abstinence throughout trial
- Fluent in English
Exclusion Criteria:
- Significant neurologic disease other than MCI
- Screening/baseline MRI scan with evidence of infection, large vessel infarction, or other focal structural lesion that could account for memory deficits; multiple lacunes or lacunes in a critical memory structure
- Contraindication to MRI (pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin or body, or excessive weight)
- Clinically significant suicide risk based on physician's judgment; suicide attempt within past year; major depression or bipolar disorder within past year; history of schizophrenia; psychotic features, agitation, or behavioral problems within last 3 months
- History of alcohol or substance abuse/dependence within past 2 years
- Allergy to atomoxetine or medical condition that could contraindicate atomoxetine (hepatic insufficiency, untreated hypertension, untreated cardiovascular or cerebrovascular disease)
- Uncontrolled medical condition that may preclude completion of study
- Known serious cardiac problems
- History of narrow angle glaucoma or pheochromocytoma
- Abnormalities in vitamin B12 level, TFTs, or LFTs that may interfere with study
- Women who are pregnant, lactating, or planning to become pregnant during study
- Prohibited medications: Current use of neuroleptics, chronic anxiolytics, sedative hypnotics; current use of warfarin; use within past 60 days of a monoamine oxidase inhibitor or potent CYP2D6 inhibitor; current use of antipsychotics or the following antidepressant medications: duloxetine, venlafaxine, desvenlafaxine, imipramine, amitryptiline
- Current/recent participation in procedures involving radioactive agents such that total radiation dose exposure to subject in any given year is more than allowable limits
- Cerebrospinal fluid profile inconsistent with underlying Alzheimer's pathology
Detailed Description:
The purpose of this study is to find out if the drug atomoxetine causes a change in the biomarkers (substances that may indicate the presence of a disease) in the CSF of people diagnosed with MCI. Atomoxetine is a drug for attention deficit hyperactivity disorder that increases levels of norepinephrine, a natural substance in the brain that regulates behavior.
The CSF of participants with MCI who take atomoxetine will be compared to the CSF of those who take a placebo. After 6 months, participants who were taking a placebo will be placed on atomoxetine, and those who received the active study medication will be reassigned to the placebo.
This study will evaluate if atomoxetine is safe and well-tolerated. Researchers will also determine the medication's effect on thinking and behavior, imaging results, and blood biomarkers. The results of this research will help determine if atomoxetine alters signs of inflammation and other biomarkers associated with Alzheimer's disease.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 33.7980995, -84.3259367 | Emory University School of Medicine | Atlanta | Georgia | 30322 | Recruiting | Margaret L. Walker, PhD 404-728-6942 mlwalke@emory.edu |
Lead Sponsor:
| Agency |
|---|
Emory University |
Collaborator Sponsor:
| Agency |
|---|
National Institute on Aging |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Allan I. Levey, MD, PhD | Principal Investigator | Emory University |
Study Contact:
| Name | Phone | |
|---|---|---|
Margaret L. Walker, PhD | 404-728-6942 |
Locations
ClinicalTrials.gov ID
NCT01522404 (follow link to view full record on ct.gov in new window)
Official Title:
A 6 Month, Phase II Randomized, Double-Blind, Placebo Controlled, Flexible Dosing, Crossover Trial of Atomoxetine in Subjects With Mild Cognitive Impairment.
Study Start Date:
March 2012
Study End Date:
February 2015
Disease Stage:
Early
Enrollment:
40
