Immunological Mechanisms Underlying Neuroprotection from Exercise in Alzheimer’s disease

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    Recruiting
Updated on 15 September 2020

Summary

This study is looking for healthy people over the age of 60. There is no treatment or experiment being tested. The study is interested in the relationship between genetics, physical activity, and the risk of developing Alzheimer’s.

Description

 
Study schedule:
-There will be an initial screening visit.

At the start of the study, you will visit the study center on three days. During those days:
-You will have a medical exam.
-You will give a blood sample.
-You will give a spinal fluid sample.
-You will do cognitive tests.
-You will have a heartbeat test (described below).
-You will do an exercise stress test.
-You will have brain scans (described below).
-You will use monitors to track your physical activity and sleep.

The study-start activities will be repeated after 12 and 24 months.
-In addition to the study visits, you will complete a short questionnaire by telephone every six months.
-The study will end after about 24 months.

Study activities may include:
-Having a medical exam.
-Having a sample of blood drawn from your arm vein, using a needle.
-Having a sample of spinal fluid drawn from your lower back (spine), using a needle. This is also known as a lumbar puncture or a spinal tap.
-Doing cognitive tests, which may be in the form of interview-style conversations, paper-and-pencil questionnaires, computer tests, and/or other activities.
-Having a heartbeat test (described below).
-Doing an exercise stress test (described below).
-Having brain scans (described below).
-Having injections as a standard part of the brain scan procedure.
-Using monitors to track your physical activity and sleep patterns.
-Answering questions over the phone.

Treatment or experiment details:
-The heartbeat test is an electrocardiogram. For this, adhesive pads will be placed on your skin and attached to a machine with wires. The machine will measure the electrical activity of your heart.
-The exercise stress test will involve doing exercise on a treadmill or stationary bicycle while wearing a heart monitor. The intensity of the exercise will gradually be increased. The test is to determine your body’s reaction to exercise.
-One of the brain scans is an MRI. For this, you will lie inside the scanning machine for about an hour while it takes a 3D image of your brain.
-The other brain scan is a PET scan. For this, you will have an injection in your arm vein. Then, you will lie inside the scanning machine for about an hour while it takes a 3D image of your brain. The injection makes proteins that are associated with Alzheimer’s visible on the scanner.
-Your blood sample will be used for genetic testing.
-There is no treatment or experiment being tested. Instead, the study is interested in observing your condition over time.

Details
Condition *Healthy Volunteers
Clinical Study IdentifierTX249129
Last Modified on15 September 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

You could be eligible for this study if
You are between the ages of 60 and 85
You are healthy
You may not be eligible for this study if
You have a neurological, medical, or psychiatric condition, including heart disease, lung disease, severe depression, or dependence on drugs or alcohol
You cannot have an MRI, for example because of metal in your body
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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