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REST

RecruitingPhase 2

Targeting 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)

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 armsSlow Wave Sleep (SWS) duration between the treatment armsSWS 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

Org study IDIRB00301426
NCT IDNCT05282550
NihR01AG071522

Timeline

Milestones

Study first posted2022-03-16actual
Study start2023-02-02actual
Last update posted2026-06-17actual
Primary completion2027-07-30estimated
Study completion2028-06-30estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersNot accepted

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

Behavior / neuropsychiatric
6
Memory
2
Other (unclassified)
1

Memory

2 endpoints
Secondary/protocol endpoint

Change in memory performance between treatment arms

Time frame:Baseline and End of study, up to 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

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 endpoints
Primary/protocol endpoint

Change in total sleep duration between the treatment arms

Time frame:Baseline and End of study, up to 12 weeks

change from baseline, improvement

Primary/protocol endpoint

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

Primary/protocol endpoint

Change in sleep onset latency between the treatment arms

Time frame:Baseline and End of study, up to 12 weeks

change from baseline, improvement

Primary/protocol endpoint

Change in sleep fragmentation between the treatment arms

Time frame:Baseline and End of study, up to 12 weeks

change from baseline, improvement

Primary/protocol endpoint

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

Primary/protocol endpoint

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 endpoint
Primary/protocol endpoint/low confidence

Change 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.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

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.