Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
55 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Johns Hopkins University · Other
Who this trial is looking for
This trial is looking for people with mild cognitive impairment who have trouble sleeping. Participants will take trazodone to see if it helps improve their sleep and memory.
Are You a Good Fit for This Trial?
Must not be takingTrazodone
Rules you outDementiaObstructive Sleep Apnea
You may be able to join if
I have mild cognitive impairment.
I have memory complaints.
I have sleep problems.
I am at least 55 years old.
I am generally in good health.
I can undergo an MRI scan.
I have a knowledgeable informant available.
I perform below the expected level on memory tests.
You may not be able to join if
I am under 55 years old.
I am too frail or medically unstable.
I have been diagnosed with obstructive sleep apnea.
I have dementia.
I have other medical conditions that explain my cognitive issues.
I have a history of delirium.
I am allergic to trazodone.
I cannot provide informed consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Mild Cognitive Impairment (MCI) as defined by Albert et al.2 including subjective memory complaint and/or objective evidence of memory problems;
2. Clinical Dementia Rating (CDR) of 0.5 with a Memory Box score of \>=0.5;
3. Evidence of sleep complaints with Pittsburgh Sleep Q…
Inclusion Criteria:
1. Mild Cognitive Impairment (MCI) as defined by Albert et al.2 including subjective memory complaint and/or objective evidence of memory problems;
2. Clinical Dementia Rating (CDR) of 0.5 with a Memory Box score of \>=0.5;
3. Evidence of sleep complaints with Pittsburgh Sleep Quality Index score of \>5 (a well-validated cutoff observed in \>40% of older persons);
4. 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;
5. Visual and auditory acuity adequate for neuropsychological testing;
6. Good general health with no disease expected to interfere with the study;
7. Able to have Magnetic Resonance Imaging (MRI) scan;
8. Availability of knowledgeable informant (KI)
9. Buschke Selective Reminding Test or more standard deviations below age-education norms
Exclusion Criteria:
1. Less than 55 years of age to reduce likelihood of including individuals with frontotemporal dementia or non-dementia MCI;
2. Too frail or medically unstable to undergo study procedures;
3. 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;
4. Dementia;
5. Cognitive complaints and deficits better explained by other medical/neurologic conditions;
6. Delirium;
7. Allergic to trazodone;
8. Taking sleep medications including trazodone;
9. Current substance abuse;
10. Current major depressive, manic, or acute psychotic episode;
11. Prior diagnosis of significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol or represent alternate primary cause of memory problems beyond Alzheimer's Disease (AD) pathology:
12. Lack of available KI;
13. Prior diagnosis of Q wave T wave Corrected for heart rate (QTc) \> 470 msec (females) or \> 450 msec (males);
14. Inability to provide informed consent
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