Phase
Condition
Narcolepsy
Restless Leg Syndrome
Insomnia
Treatment
Placebo
Trazodone
Clinical Study ID
Ages > 55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Mild Cognitive Impairment (MCI) as defined by Albert et al.2 including subjectivememory 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 (awell-validated cutoff observed in >40% of older persons);
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;
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)
Exclusion
Exclusion Criteria:
Less than 55 years of age to reduce likelihood of including individuals withfrontotemporal 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-severeOSA on baseline Home Sleep Test (HST) as evidenced by an apnea/hypopnea index of >15;
Dementia;
Cognitive complaints and deficits better explained by other medical/neurologicconditions;
Delirium;
Allergic to trazodone;
Taking sleep medications including trazodone;
Current substance abuse;
Current major depressive, manic, or acute psychotic episode;
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:
Lack of available KI;
Prior diagnosis of Q wave T wave Corrected for heart rate (QTc) > 470 msec (females)or > 450 msec (males);
Inability to provide informed consent
Study Design
Study Description
Connect with a study center
Johns Hopkins Hospital
Baltimore, Maryland 21205
United StatesActive - Recruiting
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