Status:
RECRUITING
Sleep Disturbance and Emotion Regulation Brain Dysfunction as Mechanisms of Neuropsychiatric Symptoms in Alzheimer's Dementia
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Alzheimer Disease
Mild Cognitive Impairment
Eligibility:
All Genders
50-90 years
Phase:
NA
Brief Summary
Recent findings suggest that sleep disruption may contribute to the generation and maintenance of neuropsychiatric symptoms including anxiety, depression, agitation, irritation, and apathy while treat...
Eligibility Criteria
Inclusion
- Males and females of any racial or ethnic group, aged 50-90 (inclusive)
- Subjective complaint of insomnia associated with daytime impairment or distress (ISI ≥ 10)
- Subjective complaint of sleep disturbance ≥ 3 months in duration
- Subjective complaint of Neuropsychiatric symptoms (Self-Report NPI distress total score ≥ 4 on any measure other than the sleep domain OR current symptoms from Study Partner NPI ≥ 1
- Able to verbalize understanding of involvement in the research and provide written informed consent or provide assent co-signed by a LAR
- Fluent and literate in English
- Written, informed consent
- Medications (including any dementia-related meds) stable for at least 4 weeks prior to study baseline
- Research diagnosis of memory impairment based on the following:
- i) Global Clinical Dementia Rating (CDR) of 0.5 or 1.0. OR a diagnosis of memory impairment from the Stanford/VA AD Center
- MRI safety screen passed , as assessed by the attached MRI safety screening form from the Stanford CNI, excluding mild claustrophobia that will be further screened at the in-person screening session per the screening protocol
- Have a caregiver or study partner willing to aid in facilitating the protocol and ratings
- Reside within approximately 60 miles of Stanford University
Exclusion
- less than 20 on the Mini-Mental State Examination (MMSE)
- Acute or unstable chronic illness: including but not limited to: uncontrolled thyroid disease, kidney, prostate or bladder conditions causing excessively frequent urination (\> 3 times per night); medically unstable congestive heart failure, angina, other severe cardiac illness as defined by treatment regimen changes in the prior 3 months; stroke with serious sequelae; cancer if \< 1 year since end of treatment; asthma, emphysema, or other severe respiratory diseases uncontrolled with medications; and neurological disorders (with the exception of mild AD) such as Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months; unstable adult onset diabetes as defined by treatment regimen changes in the prior 3 months.
- Use of medication specifically prescribed for sleep disturbance or nighttime-only, low dose anti-depressants (e.g., doxepin, amitriptyline, trazodone used only at sub-therapeutic anti-depressant doses and taken only at bedtime) specifically prescribed for sleep disturbance and unwilling or unable to discontinue \> two weeks (anti-depressants) or \>1 week (sleep medications) prior to baseline data collection.
- Current or lifetime history of bipolar disorder
- History of psychosis preceding onset of memory impairments
- Substance abuse or dependence
- Excessive alcohol consumption (\>14 drinks per week or \> 4 drinks per occasion)
- Current exposure to trauma, or exposure to trauma within the past 3 months
- Presence of suicidal ideations representing high risk as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS). Individuals are considered high risk if they have endorsement of either of the following:
- A score of 4 or more for the past month on the C-SSRS
- ) A positive endorsement, relative to the past 90 days, in the "Suicide Behavior" section of item #6 (Have you ever done anything, started to do anything, or prepared to do anything to end your life?)
- History of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities OR traumatic brain injury in the past two months
- Severe impediment to vision, hearing and/or hand movement, likely to interfere with the ability to complete the assessments, or are unable and/or unlikely to follow the study protocols
- Current or expected cognitive behavior therapy or other evidence based psychotherapies; therapy for another condition (e.g. Depression)
- History of falling and/or severe mobility impairment
- Individuals who are not CPAP adherent or have untreated severe OSA (AHI \>= 30).CPAP adherence being defined as using the CPAP machine 70% of nights for a minimum of 4 hours per night.
- Received Cognitive Behavior Therapy for Insomnia (CBT-I) or Desensitization Therapy for Insomnia (DTI) within the past year
- Are not fully vaccinated for COVID-19 (e.g. 2 doses of Moderna or BioNTech, Pfizer vaccines; or 1 for Johnson and Johnson) and unwilling, if asked, to provide proof (e.g., CDC COVID-19 Vaccination Card, e-Health record, etc.)
Key Trial Info
Start Date :
August 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04100057
Start Date
August 31 2021
End Date
November 30 2026
Last Update
December 17 2025
Active Locations (1)
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1
Andrea Goldstein-Piekarski, PhD
Palo Alto, California, United States, 94304