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Sponsor: Rush University Medical Center
Conditions: Cognitive Decline, Dementia, Vascular, Alzheimer Disease, Dementia, Stroke
Interventions: Behavioral Dietary intervention ( MIND Diet), Behavioral Usual Care Diet Intervention
Countries: United States
To test the effects of a 2- to 3-year intervention of the MIND diet versus usual post-stroke care on cognitive decline, the characteristic feature of dementia, and on brain biomarkers of Alzheimer's Disease (AD) and vascular disease in a Phase Ill randomized controlled trial of 250 patients hospitalized for acute ischemic stroke, aged 55 years or older, and without dementia who are discharged home following hospitalization.
Sex: ALL
Age: 55 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
* Inclusion Criteria * Men and women, 55 years of age - inclusive- or older * Acute stroke as defined by an acute focal neurological deficit in combination with one of the following: acute ischemic infarct (stroke) as documented by either a DWl positive lesion on MR imaging or a new lesion on a delayed CT scan * Written informed consent by patient prior to study participation * Willingness to complete all assessments and participate in follow-up * Willing to participate and give informed consent * Adequate Visual and auditory acuity to undergo neuropsychological testing * Exclusion criteria * CDR\>=0.5 * Nuts, berries, olive oil, or fish allergies * Use of medications to treat Alzheimer's disease or Parkinson's disease * Aphasia * Conditions of psychosis or bipolar disorder judged by study investigators to potentially interfere with study compliance over 3 years * Report of alcohol or substance abuse within six months, or heavy alcohol consumption (\>2 drinks/d women; \>3 drinks/d men) * Unstable or recent onset of cardiovascular disease, such as myocardial infarction within six months or presence of congestive heart failure (Stages II-IV) * Cancer treatment \<= 5 years except non-melanoma skin cancer , basal cell skin cancer (this criterion may be waived at the site PI's discretion) * Illness that might be associated with weight change, such as a history of stomach or gastrointestinal conditions (Inflammatory Bowel Disease, Crohn's Disease, malabsorption, colostomy, bowel resection, gastric bypass surgery, etc.) * History of liver disease, HIV or Hepatitis C * An intracerebral hemorrhage as documented on CT or MRI * Pre- hospitalization diagnosis of dementia or mild cognitive impairment * Patients presenting one of the following diseases: cerebral venous thrombosis, traumatic cerebral hemorrhage, intracerebral hemorrhage because of a known or image-guided assumed vascular malformation, pure meningeal or intraventricular hemorrhage * Patients presenting a malignant disease with life expectancy \< 3 years * Residence in a nursing home and thus going back to nursing home upon discharge * Participation in an ongoing investigational drug study * Exception to these guidelines will be rare but may be considered on a case by case basis at the discretion of the PI's
- Chicago, Illinois, United States