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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05282550
Phase
PHASE2
Status
Recruiting
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Conditions

  • AMCI - Amnestic Mild Cognitive Impairment
  • Sleep Disturbance

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trazodone — DRUG
    50mg of trazodone administered for 4 weeks.
  • Placebo — DRUG
    Placebo administered for 4 weeks.

Study Details

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).

Key Dates

Start date
Feb 2, 2023
Status verified
Sep 2025
Primary completion
Jul 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Change in total sleep duration between the treatment arms [ Time Frame: Baseline and End of study, up to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21205
Barry Greenberg, PhD
[email protected]
410-955-1696
Paul Rosenberg, MD
[email protected]
410-550-9883
Barry Greenberg, PhD (PRINCIPAL_INVESTIGATOR)

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Johns Hopkins Hospital· Baltimore, MD

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