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REST
RecruitingPhase 2Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone
RCT Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone (REST)
Lead sponsor
Asset
Trazodone
Listed sites
1
Recruiting sites
1
Enrollment
100
estimated
Study population
Alzheimer’s disease, MCI / preclinical Alzheimer’s
Key I/E criterion
•Age ≥55
Primary endpoints
•Total sleep duration between the treatment arms•Slow Wave Sleep (SWS) duration between the treatment arms•SWS intensity between the treatment arms
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Mild Cognitive Impairment (MCI) as defined by Albert et al.2 including subjective memory complaint and/or objective evidence of memory problems;
2. Clinical Dementia Rating (CDR) of 0.5 with a Memory Box score of >=0.5;
3. Evidence of sleep complaints with Pittsburgh Sleep Quality Index score of >5 (a well-validated cutoff observed in >40% of older persons);
4. 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;
5. Visual and auditory acuity adequate for neuropsychological testing;
6. Good general health with no disease expected to interfere with the study;
7. Able to have Magnetic Resonance Imaging (MRI) scan;
8. Availability of knowledgeable informant (KI)
9. Buschke Selective Reminding Test or more standard deviations below age-education norms
Exclusion criteria
1. Less than 55 years of age to reduce likelihood of including individuals with frontotemporal dementia or non-dementia MCI;
2. Too frail or medically unstable to undergo study procedures;
3. 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;
4. Dementia;
5. Cognitive complaints and deficits better explained by other medical/neurologic conditions;
6. Delirium;
7. Allergic to trazodone;
8. Taking sleep medications including trazodone;
9. Current substance abuse;
10. Current major depressive, manic, or acute psychotic episode;
11. 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:
12. Lack of available KI;
13. Prior diagnosis of Q wave T wave Corrected for heart rate (QTc) > 470 msec (females) or > 450 msec (males);
14. Inability to provide informed consent
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Memory
2 endpointsChange in memory performance between treatment arms
Time frame:Baseline and End of study, up to 12 weeks
change from baseline, improvement
Change in hippocampal activation on Function Magnetic Resonance Imaging (fMRI) measures during memory functioning between treatment arms
Time frame:Baseline and End of study, up to 12 weeks
change from baseline, improvement
Behavior / neuropsychiatric
6 endpointsChange in total sleep duration between the treatment arms
Time frame:Baseline and End of study, up to 12 weeks
change from baseline, improvement
Change in Slow Wave Sleep (SWS) duration between the treatment arms
Time frame:Baseline and End of study, up to 12 weeks
change from baseline, improvement
Change in sleep onset latency between the treatment arms
Time frame:Baseline and End of study, up to 12 weeks
change from baseline, improvement
Change in sleep fragmentation between the treatment arms
Time frame:Baseline and End of study, up to 12 weeks
change from baseline, improvement
Change in self reported sleep measure Pittsburgh Sleep Quality Index (PSQI) between treatment arms
Time frame:Baseline and End of study, up to 12 weeks
change from baseline, improvement
Change in self reported sleep measure Epworth Sleepiness Score (ESS) between treatment arms
Time frame:Baseline and End of study, up to 12 weeks
change from baseline, improvement
Other (unclassified)
1 endpointChange in SWS intensity between the treatment arms
Time frame:Baseline and End of study, up to 12 weeks
change from baseline, improvement
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID39422935via DERIVED
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.