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Aerobic Exercise + Cognitive Training for Mild Cognitive Impairment

N/A
Recruiting
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
Stable on drugs affecting cognitive and psychological status
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 3, 6, 12, and 18 months
Awards & highlights

Study Summary

This trial is testing whether a cognitive intervention can improve cognition and related brain mechanisms in older adults with aMCI.

Who is the study for?
This trial is for English-speaking adults aged 65 or older with mild cognitive impairment (MCI) who can legally consent and are living in the community. They must be able to safely exercise, have good vision, and their medication affecting cognition should be stable. People with unassessed new symptoms, enrolled in other cognitive studies, abnormal MRI results, certain heart rates or conditions that make exercise unsafe cannot join.Check my eligibility
What is being tested?
The ACT Trial investigates if a combination of aerobic exercise and cognitive training improves brain function in older adults with MCI. It compares four approaches: combined physical and mental exercises (ACT), cycling only, mental exercises only, and stretching with stimulating activities to see which has the best effect on cognition.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with moderate physical activity such as muscle soreness or strain. Cognitive training might cause temporary mental fatigue. The study will monitor participants closely for any adverse reactions.

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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My mental health medication has not changed recently.
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I have been diagnosed with mild cognitive impairment.
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I can see well enough for daily activities.
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I am able to understand and agree to the study's procedures and risks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 3, 6, 12, and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 3, 6, 12, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cognition
Secondary outcome measures
AD-signature cortical thickness
Aerobic fitness
Conversion to Alzheimer's diseae
+1 more

Side effects data

From 2020 Phase 3 trial • 310 Patients • NCT03355664
29%
anaemia
21%
thrombocytopenia
15%
aspartate transferase (AST)
14%
abdominal pain
13%
alanyl transferase (ALT)
13%
headache
11%
diarrhoea
10%
fatigue
10%
dizziness
8%
sleep disturbance
8%
vomiting
7%
nausea
6%
creatinine
6%
loss of appetite
5%
alkaline phosphatase (ALP)
3%
blurred vision
3%
itching
1%
gastritis
1%
severe malaria
1%
Transaminitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Artemether-lumefantrine for 3 Days Plus Amodiaquine for 3 Days Plus Primaquine at Hour 24
Artemether-lumefantrine for 3 Days Plus Primaquine at Hour 24

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: ACTExperimental Treatment1 Intervention
Moderate-intensity cycling followed by computerized cognitive training, 3 times a week for 6 months, supervised by a specialist
Group II: Cycling OnlyActive Control1 Intervention
Moderate-intensity cycling, 3 times a week for 6 months, supervised by an exercise specialist
Group III: Cognitive Training OnlyActive Control1 Intervention
Computerized cognitive training, 3 times a week for 6 months, supervised by a specialist
Group IV: Stretching and Mental Stimulation ActivitiesPlacebo Group1 Intervention
Stretching and mental stimulation activities, 3 times a week for 6 months, supervised by a specialist
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ACT
2017
Completed Phase 3
~5400

Find a Location

Who is running the clinical trial?

Arizona State UniversityLead Sponsor
282 Previous Clinical Trials
108,846 Total Patients Enrolled
University of RochesterOTHER
834 Previous Clinical Trials
518,021 Total Patients Enrolled
Mayo ClinicOTHER
3,190 Previous Clinical Trials
3,757,969 Total Patients Enrolled

Media Library

ACT Clinical Trial Eligibility Overview. Trial Name: NCT03313895 — N/A
Mild Cognitive Impairment Research Study Groups: Cycling Only, Cognitive Training Only, ACT, Stretching and Mental Stimulation Activities
Mild Cognitive Impairment Clinical Trial 2023: ACT Highlights & Side Effects. Trial Name: NCT03313895 — N/A
ACT 2023 Treatment Timeline for Medical Study. Trial Name: NCT03313895 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
University of Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
~4 spots leftby May 2024