Start: Jan. 4, 2023
End: May 2028
What Is This Study About?
This Phase 2 study, named REST, will examine the effectiveness of the FDA-approved drug trazodone to improve sleep and memory in people with mild cognitive impairment due to early Alzheimer's disease. Participants will be randomly assigned to take either trazodone or a placebo pill at bedtime for one month, pause for one month without pills, then switch groups for one month. Throughout the three-month study, participants will wear a sleep-monitoring device on their wrists. In addition, participants will perform and complete four home sleep tests during the study. At the start and end of the study, participants will fill out questionnaires about their sleep, complete memory tests, and undergo MRI brain scans.
Do I Qualify To Participate in This Study?
- Mild cognitive impairment due to early Alzheimer's disease, based on the study screening evaluation, including:
- Clinical Dementia Rating score of 0.5, with a Memory Box score > 0.5
- Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) list recall memory performance score > 1.5 standard deviation below cognitively normal people of the same age and education
- Evidence of sleep problems, with Pittsburgh Sleep Quality Index score of > 5
- Adequate vision and hearing to complete study tests
- Overall good health, with no disease that could interfere with the study
- Able to have Magnetic Resonance Imaging (MRI) scan
- Availability of a study partner who knows the participant well and is able to answer questions and attend study visits
Must NOT have:
- Frailty or any other condition that may interfere with ability to complete study procedures
- Diagnosis of any significant or unstable medical condition that could make it difficult to complete study procedures
- Diagnosis of obstructive sleep apnea or apnea/hypopnea index score of >15 at the start of the study
- Diagnosis of dementia
- Any medical or neurologic condition other than mild cognitive impairment that could be causing thinking and memory issues
- Allergy to trazodone
- Currently taking sleep medications, including trazodone
- Current substance abuse
- Current major depressive, manic, or acute psychotic episode
- Diagnosis of serious or unstable medical condition which could make it difficult to complete study procedures
- Any condition that may make having an MRI brain scan unsafe (e.g., metal shrapnel, heart pacemaker, severe claustrophobia, epilepsy)
- Diagnosis of long QT syndrome, a heart disorder that causes fast, chaotic heartbeats
If I Qualify, Who Do I Contact?
Contact study personnel listed either under the general study contact or the location nearest you.
Barry Greenberg, PhD
Paul Rosenberg, MD
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?
Lead: Johns Hopkins University
National Institute on Aging (NIA)
Source: ClinicalTrials.gov ID: NCT05282550