The Effect of Physical Activity on Cognition Relative to APOE Genotype



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:40 - 65
Updated:3/17/2019
Start Date:March 2019
End Date:March 2023
Contact:Shonda Mobley, MPH
Email:ypmobley@uncg.edu
Phone:(336) 334-4765

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The Effect of Physical Activity on Cognition Relative to APOE Genotype (PAAD-2)

Physical activity and Alzheimer's disease (PAAD-2) is a randomized control trial that will
assess the effects of exercise on middle-aged (40-65 years) cognitively normal adults who
have a heightened risk of Alzheimer's disease (AD) due to family history (FH+). The
investigators will also assess the extent to which this effect is moderated by apolipoprotein
epsilon-4 (APOE4) carrier status, and will gather critical new experimental evidence on the
use of physical activity to improve cognitive performance by persons at the greatest risk of
Alzheimer's disease.

In this study, the investigators follow up on their past research exploring the effects of
physical activity on cognitive performance and underlying mechanisms. In particular, the
investigators are interested in the potentially different effects that might be realized as a
function of a person's genetic risk for Alzheimer's disease. In this study, the investigators
extend past work by proposing a randomized clinical trial to: (a) test the causal link
between physical activity and cognitive performance in middle-aged adults (40-65 years) with
a family history, and (b) determine if the effect is moderated by apolipoprotein epsilon-4
(APOE4) carrier status. The investigators will collect neuroimaging measures of cerebral
structure, white matter integrity, and resting state connectivity; assess putative biological
markers; and (using moderated mediation analyses) increase understanding of underlying
mechanisms and of the extent to which effects are moderated by APOE4 carrier status. To test
hypotheses, the investigators will randomly assign 240 cognitively normal, middle-aged adults
(recruited in 4 cohorts of 60) to a 1-year physical activity program or a usual care control.
Those in the physical activity program will exercise 3 times/week for one hour at a local
Young Men's Christian Association (YMCA). Those in the usual care control condition will be
asked to maintain their normal lifestyle for one year and then will be given a short-term
YMCA membership (contingent upon completion of testing sessions). The investigators will
assess cognitive performance at pre-, mid-, and post-test, and obtain MRI scans and blood
samples at pre- and post-test. The investigators will examine the effects of physical
activity on cognitive performance and on neurological and biological mechanisms and will
explore the moderating role of APOE4.

Inclusion Criteria:

- Family History of Alzheimer's disease, cognitive impairment

- Able to communicate in English

- Not currently meeting recommendations for physical activity (the recommendations are
to exercise 3 days/week for 30+ minutes per day for longer than 3 months)

- Willing to be randomized to either study condition

- Willing to complete all study activities for 1 year

Exclusion Criteria:

- Meet the criteria for clinical cognitive impairment

- Unable to perform physical activity due to known cardiovascular, metabolic, or renal
disease and are symptomatic or due to orthopedic limitations

- Self-report history of confounding neurologic, psychiatric, or active severe or
functionally disabling neurologic or medical diseases, or any other conditions that
might limit exercise or pose a danger to the patient

- Current use of medications to treat symptoms of Alzheimer's disease, that adversely
affect cognition, or that impact heart rate

- Meet the criteria for depression using the short form of the Center for
Epidemiological Studies Depression Scale

- Traveling for an extended period (>1 month) during the course of the study
We found this trial at
1
site
Greensboro, North Carolina 27402
Phone: 336-334-4765
?
mi
from
Greensboro, NC
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