What side effects are associated with this type of intervention?

Common treatments for dementia include medications like donepezil, memantine, and antipsychotics, as well as non-pharmacological interventions such as exercise and sleep improvement. Donepezil can cause gastrointestinal issues, insomnia, and muscle cramps. Memantine may lead to dizziness, headache, and confusion. Antipsychotics, while sometimes used, have limited efficacy and can cause sedation, increased risk of falls, and cardiovascular events. Non-pharmacological approaches like exercise and improved sleep patterns generally have fewer side effects, with exercise potentially improving cognition and quality of life, and better sleep hygiene enhancing overall cognitive function.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of dementia, primarily focusing on symptomatic relief rather than disease modification. These include cholinesterase inhibitors (such as donepezil, rivastigmine, and galantamine) and an NMDA receptor antagonist (memantine). These medications aim to improve cognitive function and manage behavioral symptoms. Recent research, including trials on the influence of sleep and exercise, highlights the potential of non-pharmacological interventions to reduce dementia risk and improve cognitive health, suggesting a complementary approach to traditional drug therapies.

What other types of research exist?

Promising novel alternatives to sleep and exercise for dementia patients include: 1) Nutritionally adequate diets, which have shown potential in preventing or delaying Alzheimer's disease symptoms. 2) Cognitive Behavioral Therapy (CBT), particularly for managing insomnia and improving overall cognitive function. 3) Nonpharmacologic interventions such as mindfulness-based stress reduction, Tai Chi, and other mind-body exercises, which have demonstrated benefits in cognitive and motor functions.

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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 12 for reporting.

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 more

Awards & 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.

0 / 2Eligibility criteria met

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.