Start:
April 2012
End:
January 2017
Enrollment:
50
What Is This Study About?
This study will test the use of venlafaxine, an approved antidepressant, to treat depression in people with Alzheimer's disease. Depression affects as many as half of people at some point in the course of Alzheimer's.
Do I Qualify To Participate in This Study?
Must have:
- Dementia due to Alzheimer's disease by DSM-IV criteria
- Mini-Mental State Examination score of 10-26 inclusive; Clinical Dementia Rating Scale of 1 or 2
- Sufficiently good health to be treated using the study protocol in usual care circumstances
- Caregiver who spends at least 10 hours per week with the person, supervises care, and is willing to accompany the person to study visits and provide information
- Female participants must be at least 2 years post menopause or surgically sterilized
Must NOT have:
- Non-Alzheimer's brain disease that might otherwise fully explain the presence of dementia, such as stroke, Parkinson's disease, traumatic brain injury, multiple sclerosis, and similar neurologic diseases
- Clinically significant psychosis that requires antipsychotic treatment
- Contraindication for treatment with venlafaxine (for example, prior history of dangerous side effects); failure of past treatment with venlafaxine
- Treatment for a condition or with a medication that would prohibit the safe concurrent use of venlafaxine (specifically including systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg)
- Diagnosis of congenital long Q-T syndrome
- Need for psychiatric hospitalization for depression or suicidal
- Initiation, discontinuation, or dose changes in cholinesterase inhibitor or memantine within the 4 weeks prior to screening
Need Help?
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at
800-438-4380
or
email ADEAR.
Where Is This Study Located?
Source:
ClinicalTrials.gov ID:
NCT01609348