Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Fixing sleep may calm Alzheimer's-Related mood swings, study hints

NCT ID NCT04100057

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Alzheimer disease Cognitive Dysfunction Parasomnias sleep disorder

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.