Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone

Last updated: September 5, 2024
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

2

Condition

Narcolepsy

Restless Leg Syndrome

Insomnia

Treatment

Placebo

Trazodone

Clinical Study ID

NCT05282550
IRB00301426
R01AG071522
  • Ages > 55
  • All Genders

Study 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 time in Slow Wave Sleep (SWS).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Mild Cognitive Impairment (MCI) as defined by Albert et al.2 including subjectivememory 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 (awell-validated cutoff observed in >40% of older persons);

  4. Memory performance > 1.5 Standard Deviation (SD) below age-and education-matchedcontrol subjects on the Repeatable Battery for the Assessment of NeuropsychologicalStatus (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)

Exclusion

Exclusion Criteria:

  1. Less than 55 years of age to reduce likelihood of including individuals withfrontotemporal 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-severeOSA 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/neurologicconditions;

  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 whichcould lead to difficulty complying with the study protocol or represent alternateprimary 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

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 02, 2023
Estimated Completion Date:
June 30, 2028

Study 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. The investigators will randomize 100 subjects and administer trazodone and placebo for 4 weeks each with a 4-week washout period in between. A 4-week washout period is more than sufficient due to trazodone's elimination half-life of 10-12 hours. The crossover design will facilitate recruitment and enable the use of the subjects as a control without requiring a parallel placebo arm.

Connect with a study center

  • Johns Hopkins Hospital

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

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