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Adaptive Aerobic Exercise for Alzheimer's Disease (SMART Trial)

N/A

Recruiting

Led By Fang Yu, PhD

Research Sponsored by Arizona State University

Eligibility Criteria Checklist

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

Must have

Age 65 years and older

Clinical diagnosis of MCI or probable and possible mild AD dementia according to 2011 Alzheimer's association-NIA criteria

Must not have

≥ 2 anti-depression medications, or poorly managed or unstable depression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at 0, 3, 6, 9, & 12 months

Summary

This trial tests 6 months of supervised aerobic exercise for people 65+ w/MCI or early Alzheimer's to assess aerobic fitness, WMH volume, and patient-centered outcomes. Participants receive exercise, cognitive testing, MRI scans, and monthly health discussions.

Who is the study for?

This trial is for adults aged 65 or older with mild cognitive impairment (MCI) or early Alzheimer's Disease. They need medical clearance, a study partner who knows their memory and daily living abilities, and must be living in the community. People can't join if they have certain heart conditions, are on multiple depression medications, do other cognition interventions, exercise heavily already, or have unmanaged anxiety.

What is being tested?

The trial tests four types of exercises: Moderate Intensity Continuous Training (MICT), Chair-based Stretching, High-Intensity Interval Training (HIIT), and Combined Aerobic Resistance Exercise (CARE). It aims to see which improves aerobic fitness and memory over six months in older adults with MCI or mild Alzheimer's.

What are the potential side effects?

While not explicitly listed here, potential side effects from these exercises may include muscle soreness, fatigue, joint pain or discomfort especially if participants are not used to regular physical activity.

Eligibility Criteria

Inclusion Criteria

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

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I am 65 years old or older.

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I have been diagnosed with mild cognitive impairment or early-stage Alzheimer's.

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My study partner is 18 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 have tried at least 2 antidepressants or my depression is not well-controlled.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at 0 and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at 0 and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 0 and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Peak oxygen consumption

White Matter Hyperintensity volume

Secondary study objectives

Behavioral and psychiatric symptoms of dementia (BPSD)

Blood amyloid-beta 42 and 40

Blood phosphorylated tau 181

+5 more

Other study objectives

Anxiety

Dementia severity

Depression

+5 more

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Moderate Intensity Continuous Training (MICT)Experimental Treatment1 Intervention

Cycling on recumbent stationary cycle at moderate intensity for 30-50 minutes, 3 times per week for 3-6 months

Group II: High-Intensity Interval Training (HIIT)Active Control1 Intervention

MICT for 3 months, and then cycling on recumbent stationary cycle at alternate high and moderate intensity for 40 minutes, 3 times per week for 3 months.

Group III: Combined Aerobic Resistance Exercise (CARE)Active Control1 Intervention

MICT for 3 months, and then cycling on recumbent stationary cycle at moderate intensity for 30 minutes, followed by 20-minute strength-building exercise, 3 times per week for 3 months.

Group IV: Chair-based StretchPlacebo Group1 Intervention

Stretching at low intensity for 30-50 minutes, 3 times per week for 6 months

0 / 4Eligibility criteria met