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MIND Diet for Cognitive Decline
N/A
Recruiting
Led By Christy Tangney, PhD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate visual and auditory acuity to undergo neuropsychological testing
Acute stroke as defined by an acute focal neurological deficit in combination with acute ischemic infarct (stroke) as documented by either a DWI positive lesion on MR imaging or a new lesion on a delayed CT scan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-years
Awards & highlights
Study Summary
This trial will test the effects of the MIND diet on cognitive decline, dementia, and brain biomarkers of Alzheimer's Disease and vascular disease in 500 patients who have had a stroke.
Who is the study for?
This trial is for stroke patients aged 55 or older, who are going home after hospitalization and can give consent. They must be able to see and hear well enough for tests, have had an acute ischemic stroke confirmed by MRI or CT scan, but not have dementia or cognitive impairment before the stroke.Check my eligibility
What is being tested?
The study compares the MIND diet—a specific dietary plan designed to reduce neurodegenerative decline—with usual care diets in post-stroke patients. It aims to observe effects on cognitive decline and brain markers related to Alzheimer's Disease over a period of 2-3 years.See study design
What are the potential side effects?
Since this trial involves dietary interventions rather than medications, side effects may include changes in digestion or food sensitivities due to new eating habits. However, no significant medical side effects like those seen with drugs are expected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can see and hear well enough to take psychological tests.
Select...
I recently had a stroke confirmed by an MRI or a CT scan.
Select...
I can see and hear well enough to take psychological tests.
Select...
I am 55 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in global cognitive score
Secondary outcome measures
Change in 5 individual cognitive domains
Change in brain MRI derived markers of macro and micro structural integrity (cubic Centimeters), total brain volume, hippocampal volume and white matter hyperintensity volume ( cubic centimeters)
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: MIND DIET interventionActive Control1 Intervention
Allocation and blinding 3 year intervention of MIND Diet + counseling
Group II: Usual care diet interventionPlacebo Group1 Intervention
3 year Intervention of usual care diet + counseling
Find a Location
Who is running the clinical trial?
Advocate Hospital SystemOTHER
4 Previous Clinical Trials
218 Total Patients Enrolled
University of ChicagoOTHER
1,004 Previous Clinical Trials
819,277 Total Patients Enrolled
4 Trials studying Dementia
2,418 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,425 Total Patients Enrolled
268 Trials studying Dementia
23,627,106 Patients Enrolled for Dementia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You live in a nursing home and will return there after leaving the study.I haven't had cancer treatment in the last 5 years, except for non-melanoma skin cancers.I have a brain-related blood clot or bleeding due to a vascular issue.I have not had a heart attack in the last 6 months or severe heart failure.I have a condition like Crohn's or had surgery that affects my digestion and weight.I can see and hear well enough to take psychological tests.You have had issues with alcohol or drug abuse in the past six months, or you drink more than 2 drinks a day if you're a woman or 3 drinks a day if you're a man.I was diagnosed with dementia or mild cognitive impairment before being hospitalized.I recently had a stroke confirmed by an MRI or a CT scan.You are allergic to nuts, berries, olive oil, or fish.You have had bleeding inside your brain as shown on a CT or MRI scan.You have been diagnosed with severe mental health conditions that may make it difficult for you to follow the study guidelines for 3 years.I am taking medication for Alzheimer's or Parkinson's disease.I have a history of liver disease, HIV, or Hepatitis C.Difficulty speaking or understanding languageYour ability to take care of yourself is not severely limited.I am willing to complete all required assessments and follow-ups.My doctor expects I have less than 3 years to live due to my cancer.I can see and hear well enough to take psychological tests.I am 55 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: MIND DIET intervention
- Group 2: Usual care diet intervention
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Dementia Patient Testimony for trial: Trial Name: NCT04337255 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the upper limit of enrollees for this clinical trial?
"Affirmative. According to clinicaltrials.gov, this study is actively recruiting participants and has been since the 14th of December 2021. The most recent edit was made on May 30th 2022 with a goal of enlisting 500 patients from one site."
Answered by AI
Are there any current vacancies in the clinical trial?
"Yes, the details on clinicaltrials.gov show that this research is actively seeking participants. The study was initiated on December 14th 2021 and updated as recently as May 30th 2022. 500 individuals are needed to be recruited from 1 medical facility."
Answered by AI
Does this trial accept participants above the age of twenty?
"The enrollment parameters for this trial demand that participants are at least 55 years old, with the upper threshold set to 80."
Answered by AI
Is eligibility for this trial restricted or open to all?
"This clinical experiment is seeking to recruit 500 people aged 55-80 who have been diagnosed with dementia and vascular disease."
Answered by AI
Who else is applying?
What state do they live in?
Illinois
What site did they apply to?
Rush University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have 3 1st cousins who have developed dementia.
PatientReceived 2+ prior treatments
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