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New treatment option for AMCI - Amnestic Mild Cognitive Impairment
Official title Targeting Cognition in Early Alzheimer's Disease by Improving Sleep With Trazodone
ClinicalTrials.gov ID: NCT05282550
What this study is testing
What is Trazodone?
Trazodone is an investigational medicine, being studied as a potential treatment for amci - amnestic mild cognitive impairment.
Also referred to as Desyrel.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- 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 people on the Repeatable Battery for the Assessment of...
- Visual and auditory acuity adequate for neuropsychological testing;
You likely can't join if
- 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...
- Dementia;
- Cognitive complaints and deficits better explained by other medical/neurologic conditions;
- Delirium;
See the full eligibility criteria
- 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 people on the Repeatable Battery for the Assessment of Neuropsychological Status (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)
- Buschke Selective Reminding Test or more standard deviations below age-education norms
- 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;
- Cognitive complaints and deficits better explained by other medical/neurologic conditions;
- 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 which could lead to difficulty complying with the study protocol or represent alternate primary cause of memory problems beyond Alzheimer's...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.