Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55+
SponsorJohns Hopkins University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
Less than 55 years of age to reduce likelihood of including individuals with frontotemporal dementia or non-dementia MCI;
Too frail or medically unstable to undergo study procedures;
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;
Dementia;
Trial design
Design model
Crossover
Treatments tested in this trial
Trazodone
Drug50mg of trazodone administered for 4 weeks.
Placebo
DrugPlacebo administered for 4 weeks.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Trazodone FirstActive comparator 2 interventions
Group B: Placebo FirstPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Change in total sleep duration between the treatment arms
Comparison of means of total sleep duration from baseline measured in minutes between trazodone and placebo arm.
Time frame
Baseline and End of study, up to 12 weeks2
Change in Slow Wave Sleep (SWS) duration between the treatment arms
Comparison of means of SWS from baseline measured in minutes between trazodone and placebo arm.
Time frame
Baseline and End of study, up to 12 weeks3
Change in SWS intensity between the treatment arms
Comparison of means of SWS intensity measured from baseline in volts squared between trazodone and placebo arm.
Time frame
Baseline and End of study, up to 12 weeks4
Change in sleep onset latency between the treatment arms
Comparison of means of sleep onset latency from baseline measured in minutes between trazodone and placebo arm.
Time frame
Baseline and End of study, up to 12 weeksSecondary outcomes
1
Change in memory performance between treatment arms
Comparison of means for memory performance from baseline measured in percent correct between trazodone and placebo arm.
Time frame
Baseline and End of study, up to 12 weeks2
Change in hippocampal activation on Function Magnetic Resonance Imaging (fMRI) measures during memory functioning between treatment arms
Comparison of means of hippocampal activation on fMRI measures calculated as a beta weight reflecting relative activation during memory functioning from baseline between trazodone and placebo arm. Higher activation suggests a worse outcome.
Time frame
Baseline and End of study, up to 12 weeksSponsors and contacts
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Johns Hopkins University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov