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
Qualifiers
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
Treatments tested in this trial
- Trazodone
- Placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov