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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have been diagnosed with mild cognitive impairment or mild Alzheimer's Disease.
Select...
My recent scans show no signs of infection, stroke, or other brain issues.
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I am 65 years old or older.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants enrolled to the study
Number of participants that complete the study
Secondary outcome measures
Cognitive function assessed by standard neurocognitive battery
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
~150
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,515 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,973 Total Patients Enrolled
Yue Leng, PhDPrincipal InvestigatorUniversity of California, San Francisco
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies for participants in this experiment?
"Yes, records on clinicaltrials.gov show that this research is actively seeking participants. This experiment was initially posted on the 12th of August 2021 and updated lastly on 5th October 2022; 40 volunteers are necessary from a single trial site."
Answered by AI
What is the current participant population of this clinical research?
"Indeed. According to clinicaltrials.gov, this medical trial began on August 12th 2021 and was most recently updated October 5th 2022. The study is looking for 40 participants at a single research site."
Answered by AI
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