ENLIGHTEN: Exercise and NutritionaL Interventions for coGnitive and Cardiovascular HealTh ENhancement

Cardiovascular disease (CVD) is the leading cause of death and disability in the United
States, affecting more than 81 million American adults. It is well established that risk
factors such as hypertension, diabetes, and hyperlipidemia not only place individuals at risk
for CVD, but also place them at risk for neurocognitive impairment and dementia. CVD risk
factors have been shown to be associated with a cascade of neurophysiologic and neuroanatomic
changes, resulting in cognitive impairment and dementia. Exercise and diet have been shown to
improve CVD risk factors and also appear particularly promising lifestyle approaches for
preventing dementia among individuals at risk, such as those with cognitive impairment, no
dementia (CIND). ENLIGHTEN is a randomized clinical trial of diet and exercise among patients
with CIND.

Inclusion Criteria:

- Age 55 years or older

- Sedentary

- Score of 19-25 on the Montreal Cognitive Assessment Battery or verbal fluency score of
=< 12 or animal fluency score of =<15

- At least one cardiovascular risk factor (hypertension, diabetes, cholesterol, obesity,
current smoking, or family history) or a documented history of cardiac disease
(myocardial infarction, coronary artery bypass grafting, peripheral vascular disease,
>70% stenosis, or mild stroke without residual deficit)

Exclusion Criteria:

- Any significant neurological disease other than CIND, such as Parkinson's disease,
multi-infarct dementia, Huntington' s disease, progressive supranuclear palsy, brain
tumor, normal pressure hydrocephalus, subdural hematoma, seizure disorder, multiple
sclerosis, or history of head trauma with persistent neurological deficits

- Psychotic disorder within the past two years (DSM IV criteria) or acutely suicidal

- History of alcohol or substance abuse or dependence within the past two years (DSM IV
criteria)

- History of schizophrenia

- Any significant systemic illness or unstable medical condition that could lead to
difficulty in complying with the protocol including a history of systemic cancer
within the past 5 years (nonmetastatic skin cancers are acceptable)

- Myocardial infarction (within the past 3 months) or unstable or severe congestive
heart failure (e.g. class III-IV heart failure)

- End-stage pulmonary disease; uncontrolled diabetes mellitus or uncontrolled
hypertension(systolic BP>170 or diastolic BP >100 mm Hg on medication)

- Musculoskeletal disorders precluding the ability to exercise (e.g. severe arthritis)