RCT Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone (REST)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• 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)

Locations
United States
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Contact Information
Primary
Barry Greenberg, PhD
bgreen45@jhmi.edu
410-955-1696
Backup
Paul Rosenberg, MD
prosenb9@jhmi.edu
410-550-9883
Time Frame
Start Date: 2023-02-02
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 100
Treatments
Active_comparator: Trazodone First
Trazodone (50 mg at bedtime) and then placebo after a 4-week washout period.
Placebo_comparator: Placebo First
Placebo and then Trazodone (50 mg at bedtime) after a 4-week washout period.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov