Fast Facts
Ages 55+
Experiencing memory difficulties or have concerns with memory
Compensation Provided
Conducted in Baltimore, MD
Study Background
Sleep disturbances are common in early Alzheimer’s disease and may worsen cognitive decline. Addressing sleep issues could offer a new way to improve memory and brain health. The REST study (RCT Targeting Cognition in Early Alzheimer’s Disease by Improving Sleep with Trazodone) is a randomized controlled trial exploring whether trazodone, an FDA-approved medication often used off-label for sleep, can enhance both sleep and memory in older adults with memory concerns.
The study involves five visits to Johns Hopkins over 13 to 15 weeks. Participants will take trazodone and a placebo during two 4-week periods, separated by a 4-week washout. Both participants and investigators will be blinded to the treatment order. Evaluations include health and memory assessments, three MRI brain scans, blood tests, and cognitive tests. Participants will also wear an actigraph to track movement and complete four home sleep studies. These measures aim to uncover how trazodone affects sleep quality and cognitive function.
Study Background
Help us explore whether trazodone can improve sleep and memory in older adults with memory and sleep difficulties.
Sleep disturbances are common in early Alzheimer’s disease and may worsen cognitive decline. Addressing sleep issues could offer a new way to improve memory and brain health. The REST study (RCT Targeting Cognition in Early Alzheimer’s Disease by Improving Sleep with Trazodone) is a randomized controlled trial exploring whether trazodone, an FDA-approved medication often used off-label for sleep, can enhance both sleep and memory in older adults with memory concerns.
The study involves five visits to Johns Hopkins over 13 to 15 weeks. Participants will take trazodone and a placebo during two 4-week periods, separated by a 4-week washout. Both participants and investigators will be blinded to the treatment order. Evaluations include health and memory assessments, three MRI brain scans, blood tests, and cognitive tests. Participants will also wear an actigraph to track movement and complete four home sleep studies. These measures aim to uncover how trazodone affects sleep quality and cognitive function.
Additional Information
You may qualify for a study if you meet the following criteria.
Inclusion Criteria:
- Ages 55+
- Experiencing memory difficulties or have concerns with memory
- Having trouble sleeping
- Have someone who can serve as a study partner
- In good general health
- Able to undergo an MRI (no non-removable metal on or in your body)
Exclusion Criteria:
- Diagnosed with sleep apnea or use a CPAP
- Currently using trazodone
- Use of other sleep medications unless willing to undergo a “washout: before beginning the study
If you participate in this study, here is what you can expect:
Study Visits: You will have five visits to Johns Hopkins over a 13 to 15-week period.
Study Drug Periods: You will take either trazodone or a placebo (a sugar pill) for the first 4 weeks, followed by a 4-week break (washout period), and then switch to the other for another 4 weeks. Neither you nor the researchers will know the order of the treatments (blinded study).
Health and Memory Evaluations: A doctor will evaluate your health, memory, and daily activities during the study.
Brain Imaging: You will undergo three magnetic resonance imaging (MRI) scans of your brain.
Cognitive and Blood Tests: You will complete pencil-and-paper cognitive tests and provide blood samples.
Activity Monitoring: You will wear an actigraph (a wristwatch-like device) to track your movement.
Sleep Studies: You will participate in four home sleep studies, each lasting one night.
These steps will help researchers assess how the study drug affects sleep and memory.
Participants can drop out of the study at any time.
There will be no costs for your participation and parking will be provided at each visit. You will receive compensation for each visit, ranging from $25 to $75. If you complete all five visits, you will receive $275.
There is no cost for you to participate in our research study.
