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Behavioural Intervention
Sleep and Exercise for Alzheimer's Disease (CASE Trial)
N/A
Recruiting
Led By Azizi A Seixas, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Self-reported history of problems with cognitive impairment: memory, concentration, and processing information
Be older than 18 years old
Must not have
Unable to use mobile device/smartphone technology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 12
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying whether better sleep and more exercise can reduce the risk of dementia in people who are at risk. The idea is that these lifestyle changes might help keep the brain healthy.
Who is the study for?
This trial is for individuals experiencing memory, concentration, or information processing issues who can do mild exercise and wear a DREEM 2 Headband and Fitbit watch. They must be able to handle a digital device and perform the Everlywell biomarker test. Participants should speak English and consent willingly.
What is being tested?
The study examines how sleep quality and an exercise routine might influence dementia risk over time using tools like the DREEM 2 Headband to monitor sleep patterns and a Fitbit watch to track activity levels.
What are the potential side effects?
Potential side effects may include discomfort from wearing the headband or wristwatch devices continuously, skin irritation from prolonged device contact, muscle soreness from exercise routines, or stress related to blood sample collection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have issues with memory, focusing, or understanding information.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot use a smartphone or similar technology.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Blood Pressure
Cortisol Levels
Cortisone Levels
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Sleep Only GroupExperimental Treatment1 Intervention
Participants in this group will wear the DREEM 2 headband for 12 weeks.
Group II: Exercise Only GroupActive Control1 Intervention
Participants in this group will workout twice a week for 12 weeks.
Group III: Exercise and Sleep GroupActive Control2 Interventions
Participants in this group will take part in a guided exercise program in additional to wearing the DREEM 2 headband for 12 weeks.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for dementia include nonpharmacologic interventions like sleep optimization and exercise, and pharmacologic treatments such as galantamine. Sleep optimization involves maintaining consistent sleep-wake schedules and using light therapy to stabilize circadian rhythms, which can improve cognitive function and overall quality of life.
Exercise, particularly moderate to high-intensity, has been shown to enhance sleep quality and may have neuroprotective effects, potentially slowing cognitive decline. Galantamine, a cholinesterase inhibitor, works by increasing acetylcholine levels in the brain, which helps improve memory and cognitive function.
These treatments are crucial for dementia patients as they address both cognitive symptoms and overall well-being, potentially delaying disease progression and enhancing daily functioning.
Recent advances in the management of neuropsychiatric symptoms in dementia.Effect of galantamine on verbal repetition in AD: a secondary analysis of the VISTA trial.
Recent advances in the management of neuropsychiatric symptoms in dementia.Effect of galantamine on verbal repetition in AD: a secondary analysis of the VISTA trial.
Find a Location
Who is running the clinical trial?
DreemIndustry Sponsor
6 Previous Clinical Trials
248 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,408 Previous Clinical Trials
855,755 Total Patients Enrolled
University of MiamiLead Sponsor
948 Previous Clinical Trials
427,740 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am mentally capable and agree to participate.You are not allowed to do light exercise or have difficulty doing so.I can do the Everlywell biomarker test.I can use a smartphone, tablet, or computer.I have issues with memory, focusing, or understanding information.I cannot use a smartphone or similar technology.You are able to do light physical activity.I can wear a Fitbit wrist watch.Can wear the DREEM 2 Headband
Research Study Groups:
This trial has the following groups:- Group 1: Sleep Only Group
- Group 2: Exercise Only Group
- Group 3: Exercise and Sleep Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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