Status:
RECRUITING
Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
AMCI - Amnestic Mild Cognitive Impairment
Sleep Disturbance
Eligibility:
All Genders
55+ years
Phase:
PHASE2
Brief Summary
To investigate the effect of trazodone on sleep, hippocampal-dependent memory and hippocampal excitability. The investigators hypothesize that trazodone will improve total sleep time and proportion of...
Detailed Description
The REST trial is a randomized, placebo-controlled, double-blind crossover study of trazodone (50 mg at bedtime) in participants with Amnestic Mild Cognitive impairment (aMCI) and sleep complaints. Th...
Eligibility Criteria
Inclusion
- Mild Cognitive Impairment (MCI) as defined by Albert et al.2 including subjective memory complaint and/or objective evidence of memory problems;
- Clinical Dementia Rating (CDR) of 0.5 with a Memory Box score of \>=0.5;
- Evidence of sleep complaints with Pittsburgh Sleep Quality Index score of \>5 (a well-validated cutoff observed in \>40% of older persons);
- Memory performance \> 1.5 Standard Deviation (SD) below age-and education-matched control subjects on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) List Recall;
- Visual and auditory acuity adequate for neuropsychological testing;
- Good general health with no disease expected to interfere with the study;
- Able to have Magnetic Resonance Imaging (MRI) scan;
- Availability of knowledgeable informant (KI)
Exclusion
- Less than 55 years of age to reduce likelihood of including individuals with frontotemporal dementia or non-dementia MCI;
- Too frail or medically unstable to undergo study procedures;
- Prior diagnosis of Obstructive Sleep Apnea (OSA) or evidence of moderate-to-severe OSA on baseline Home Sleep Test (HST) as evidenced by an apnea/hypopnea index of \>15;
- Dementia;
- Cognitive complaints and deficits better explained by other medical/neurologic conditions;
- Delirium;
- Allergic to trazodone;
- Taking sleep medications including trazodone;
- Current substance abuse;
- Current major depressive, manic, or acute psychotic episode;
- Prior diagnosis of significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol or represent alternate primary cause of memory problems beyond Alzheimer's Disease (AD) pathology:
- Lack of available KI;
- Prior diagnosis of Q wave T wave Corrected for heart rate (QTc) \> 470 msec (females) or \> 450 msec (males);
- Inability to provide informed consent
Key Trial Info
Start Date :
February 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05282550
Start Date
February 2 2023
End Date
June 30 2028
Last Update
September 18 2025
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205