Fixing sleep may calm Alzheimer's-Related mood swings, study hints
NCT ID NCT04100057
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether improving sleep through cognitive behavioral therapy (CBT-I) can reduce neuropsychiatric symptoms like anxiety, depression, and agitation in 150 older adults with mild cognitive impairment or early Alzheimer's. Participants are randomly assigned to CBT-I or an active control group. The researchers will use brain scans and sleep tracking to understand how sleep affects emotion regulation in the brain.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cognitive Behavioral Therapy for Insomnia (CBT-I)
- What this could lead to
- If successful, this could show that treating insomnia helps ease anxiety, depression, and agitation in people at risk for Alzheimer's disease.
- What could go wrong
- This is a small, early-stage study focused on understanding brain mechanisms, not a treatment trial. Results may not lead to a new therapy or apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2021
- Expected to finish
-
Nov 2026
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 to 90 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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: 1. A score of 4 or more for the past month on the C-SSRS 2. ) 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.)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Alzheimer disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Andrea Goldstein-Piekarski, PhD
Palo Alto, California, 94304, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gut bacteria may hold clues to dozens of diseases
- Can a personalized home program slow memory decline?
- Can a sleep drug help cirrhosis patients rest and think clearer?
- Can a massive data registry crack the code of Parkinson's and related brain diseases?
- Can a gentle electric current calm the mind in Alzheimer's?
- Alzheimer's vaccine aims to clear amyloid before memory fades