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Sleep Intervention for Alzheimer's Disease

N/A

Recruiting

Led By Yue Leng, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of mild cognitive impairment (MCI) or mild Alzheimer's Disease

No evidence (CT or MRI scans within 12 months prior to screening) of infection, infarction, or other focal lesions and no clinical symptoms suggestive of intervening neurological disease

Must not have

Any major neurologic disease other than suspected incipient Alzheimer's disease, such as Parkinson's disease, multi-infarct dementia, multiple sclerosis, seizure disorder, Huntington's disease, brain tumor or history of significant head trauma

Any inadequately treated primary or secondary sleep disorder (due to medical conditions) that might confound the association

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Summary

This trial will test a behavioral treatment program to improve cognition in people with mild Alzheimer's disease by improving their sleep-wake cycle.

Who is the study for?

This trial is for people aged 65 or older with mild cognitive impairment (MCI) or early Alzheimer's, who experience sleep disturbances and napping issues. They must have good vision and hearing for tests, no major neurological diseases other than Alzheimer's, no severe psychiatric conditions in the past two years, and not be struggling with substance abuse.

What is being tested?

The study is testing a non-drug program designed to improve cognition by regulating the sleep-wake cycle using bright light therapy and modified cognitive behavioral therapy for insomnia. It aims to see if this can help patients with MCI or early Alzheimer's improve their sleep patterns and mental function.

What are the potential side effects?

Since the interventions are behavioral rather than medicinal, side effects may include discomfort from bright light therapy or stress from changing sleeping habits. However, significant physical side effects are unlikely compared to drug treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with mild cognitive impairment or mild Alzheimer's Disease.

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My recent scans show no signs of infection, stroke, or other brain issues.

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I am 65 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have major neurological diseases except for possible early Alzheimer's.

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I have a sleep disorder that hasn't been properly treated.

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I haven't had major mental health issues like depression, bipolar, or schizophrenia in the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Sleep as assessed by actigraphy

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Sleep InterventionExperimental Treatment1 Intervention

Sleep treatment program (to be developed) that incorporates modified cognitive behavioral therapy for insomnia (CBT-I) and bright light therapy (BLT)

Group II: Placebo interventionPlacebo Group1 Intervention

Placebo (quasi-desensitization) intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sleep intervention

2011

N/A

~210

0 / 6Eligibility criteria met