Cognitive DeclineNCT04337255
Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) Diet in Stroke Patients Patients
A study testing Behavioral Dietary intervention ( MIND Diet) in people with Cognitive Decline and Dementia, Vascular, run by Rush University Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cognitive Decline, Dementia, Vascular, Alzheimer Disease
- What is being tested?
- Behavioral Dietary intervention ( MIND Diet)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 266 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: MIND Diet and Dementia Prevention in Ischemic Stroke Patients
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.
Read the detailed description
The Mediterranean-DASH diet intervention for Neurodegenerative Delay (MIND in Stroke patients is designed to test the effects of a 2-3 year intervention of a hybrid of the Mediterranean and DASH diets, called MIND on 250 older patients, without dementia who are hospitalized for acute stroke who are discharged home following hospitalization. The MIND diet has the same basic components of the DASH and Mediterranean diets, such as emphasis on natural plant based foods and limited animal and high saturated fat foods, but uniquely specifies green leafy vegetable and berries as well as food component servings that reflect the nutrition dementia evidence. In this study we will test the effects of a 2- to 3-year intervention of the MIND diet (3 months of delivered meals followed by dietary and general stroke health counseling) versus usual post-stroke care (3 months delivered self-selected meals followed by general stroke health counseling) on change on cognitive outcomes over 24 to 36 months. Biological effects of the MIND diet will be assessed by measurement of brain macro and microstructural integrity in all trial participants. Other biochemical markers will be assessed in the entire group of 250 participants including: plasma Abeta42/beta40, brain derived neurotropic factor (BDNF) and plasma markers of oxidative stress and inflammation. The trial will examine potential effect mediators and modifiers by a number of cardiovascular risk factors, AD biomarkers and biological mechanisms. The proposed study has 3 recruitment sites, Rush University Medical Center, University of Chicago, and Advocate Christ Hospital all located in Chicago.
- Conditions
- Cognitive Decline, Dementia, Vascular, Alzheimer Disease, Dementia, Stroke
- Being tested
- Behavioral Dietary intervention ( MIND Diet), Behavioral Usual Care Diet Intervention
- Medical subject headings
- Cognitive Dysfunction, Dementia, Vascular, Alzheimer Disease, Dementia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Dietary intervention ( MIND Diet)Other
The MIND diet is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet dementia field. The MIND diet has the same basic components of the DASH and Mediterranean diets, such as emphasis on natural plant based foods and limited animal and high saturated fat foods, but uniquely specifies green leafy vegetables and berries as well as food component servings that reflect the nutrition dementia evidence.
Behavioral Usual Care Diet InterventionOther
The Usual Care diet is comprised of both westernized (e.g. Steak, Mac n Cheese) and healthy ( veggie chili) food components
| Study group | Role | What they receive |
|---|---|---|
| MIND DIET intervention | Active comparator | Allocation and blinding 3 year intervention of MIND Diet + counseling Receives: Other: Behavioral Dietary intervention ( MIND Diet) |
| Usual care diet intervention | Placebo comparator | 3 year Intervention of usual care diet + counseling Receives: Other: Behavioral Usual Care Diet Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global cognitive score
3-year change in global cognitive score. The global cognitive score is a composite score, based on the average of z scores of the 19 individual tests scores, with a mean of 0 and standard deviation of 1. Higher scores reflect high global cognitive function.
Measured: 3-years
Secondary outcomes (2)
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)
130 participants total ( 65 in each treatment group)
Measured: 3-years
Change in 5 individual cognitive domains
Change in 5 individual domains that include executive functioning, perceptual speed, episodic memory, semantic and working memory. Each domain is made up of atleast 2 cognitive tests that are z scored and averaged for that domain. Higher scores on each domain reflects higher cognition in that domain.
Measured: 3-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start14 Dec 2021
- Primary completion31 Jul 2026
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Model description
- MIND diet intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, Advocate Hospital System, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Neelum T. Aggarwal, MD, Rush University Medical Center
- Investigators
- Neelum T Aggarwal, MD., Principal investigator, Rush University Medical CenterChristy Tangney, PhD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337255
- Sponsor's protocol ID
- 18052104-IRB01
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2019
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Electronic data will be made available after trial completion
Publications
Halloway S, Dhana K, Desai P, Agarwal P, Holland T, Aggarwal NT, Evers J, Sacks FM, Carey VJ, Barnes LL. Free-Living Standing Activity as Assessed by Seismic Accelerometers and Cognitive Function in Community-Dwelling Older Adults: The MIND Trial. J Gerontol A Biol Sci Med Sci. 2021 Oct 13;76(11):1981-1987. doi: 10.1093/gerona/glab106.
PubMed 33835152Dhana K, Aggarwal NT, Voigt RM, Ventrelle J, Rajan KB, Kaddurah-Daouk R, Marcovina SM, Liu X, Agarwal P, Tangney C, Arfanakis K, Sacks FM, Barnes LL. Effect of weight loss through dietary interventions on cardiometabolic health in older adults. Int J Obes (Lond). 2025 Dec;49(12):2503-2510. doi: 10.1038/s41366-025-01902-6. Epub 2025 Oct 3.
PubMed 41044190Liu X, Dhana K, Furtado JD, Agarwal P, Aggarwal NT, Tangney C, Laranjo N, Carey V, Barnes LL, Sacks FM. Higher circulating alpha-carotene was associated with better cognitive function: an evaluation among the MIND trial participants. J Nutr Sci. 2021 Aug 16;10:e64. doi: 10.1017/jns.2021.56. eCollection 2021.
PubMed 34527222Liu X, Morris MC, Dhana K, Ventrelle J, Johnson K, Bishop L, Hollings CS, Boulin A, Laranjo N, Stubbs BJ, Reilly X, Carey VJ, Wang Y, Furtado JD, Marcovina SM, Tangney C, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline. Contemp Clin Trials. 2021 Mar;102:106270. doi: 10.1016/j.cct.2021.106270. Epub 2021 Jan 9.
PubMed 33434704Barnes LL, Dhana K, Liu X, Carey VJ, Ventrelle J, Johnson K, Hollings CS, Bishop L, Laranjo N, Stubbs BJ, Reilly X, Agarwal P, Zhang S, Grodstein F, Tangney CC, Holland TM, Aggarwal NT, Arfanakis K, Morris MC, Sacks FM. Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons. N Engl J Med. 2023 Aug 17;389(7):602-611. doi: 10.1056/NEJMoa2302368. Epub 2023 Jul 18.
PubMed 37466280Dhana K, Aggarwal NT, Ventrelle J, Voigt RM, Liu X, Agarwal P, Tangney C, Arfanakis K, Sacks FM, Barnes LL. Adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet and longitudinal changes in global cognition: a post hoc analysis of the MIND trial. Am J Clin Nutr. 2026 Jul 15;124(3):101433. doi: 10.1016/j.ajcnut.2026.101433. Online ahead of print.
PubMed 42457038Dhana K, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Dietary intervention and cognition across Alzheimer's disease biomarker levels: The MIND clinical trial. J Alzheimers Dis. 2026 Jun;111(3):1301-1308. doi: 10.1177/13872877261442856. Epub 2026 Apr 25.
PubMed 42033408Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15.
PubMed 26086182Morris MC, Tangney CC, Wang Y, Sacks FM, Bennett DA, Aggarwal NT. MIND diet associated with reduced incidence of Alzheimer's disease. Alzheimers Dement. 2015 Sep;11(9):1007-14. doi: 10.1016/j.jalz.2014.11.009. Epub 2015 Feb 11.
PubMed 25681666Ventrelle J, Lukaszewicz B, Claysen M, Setia B, Aggarwal NT, Tangney CC; NOURISH Study Team. A framework for monitoring intervention fidelity: The NOURISH trial. Contemp Clin Trials. 2025 Nov;158:108104. doi: 10.1016/j.cct.2025.108104. Epub 2025 Oct 4.
PubMed 41052713Cherian L, Wang Y, Fakuda K, Leurgans S, Aggarwal N, Morris M. Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) Diet Slows Cognitive Decline After Stroke. J Prev Alzheimers Dis. 2019;6(4):267-273. doi: 10.14283/jpad.2019.28.
PubMed 31686099
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIND Diet and Dementia Prevention in Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT04337255
- Acronym / sponsor ID
- 18052104-IRB01
- Conditions
- Cognitive Decline, Dementia, Vascular, Alzheimer Disease, Dementia, Stroke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- University of Chicago, Advocate Hospital System, National Institute on Aging (NIA)
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Mediterranean-DASH diet intervention for Neurodegenerative Delay (MIND in Stroke patients is designed to test the effects of a 2-3 year intervention of a hybrid of the Mediterranean and DASH diets, called MIND on 250 older patients, without dementia who are hospitalized for acute stroke who are discharged home following hospitalization. The MIND diet has the same basic components of the DASH and Mediterranean diets, such as emphasis on natural plant based foods and limited animal and high saturated fat foods, but uniquely specifies green leafy vegetable and berries as well as food component servings that reflect the nutrition dementia evidence. In this study we will test the effects of a 2- to 3-year intervention of the MIND diet (3 months of delivered meals followed by dietary and general stroke health counseling) versus usual post-stroke care (3 months delivered self-selected meals followed by general stroke health counseling) on change on cognitive outcomes over 24 to 36 months. Biological effects of the MIND diet will be assessed by measurement of brain macro and microstructural integrity in all trial participants. Other biochemical markers will be assessed in the entire group of 250 participants including: plasma Abeta42/beta40, brain derived neurotropic factor (BDNF) and plasma markers of oxidative stress and inflammation. The trial will examine potential effect mediators and modifiers by a number of cardiovascular risk factors, AD biomarkers and biological mechanisms. The proposed study has 3 recruitment sites, Rush University Medical Center, University of Chicago, and Advocate Christ Hospital all located in Chicago.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- MIND diet intervention
| Arm | Type | Receives |
|---|---|---|
| MIND DIET intervention | Active comparator | Other: Behavioral Dietary intervention ( MIND Diet)Allocation and blinding 3 year intervention of MIND Diet + counseling |
| Usual care diet intervention | Placebo comparator | Other: Behavioral Usual Care Diet Intervention3 year Intervention of usual care diet + counseling |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Dietary intervention ( MIND Diet)The MIND diet is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet dementia field. The MIND diet has the same basic components of the DASH and Mediterranean diets, such as emphasis on natural plant based foods and limited animal and high saturated fat foods, but uniquely specifies green leafy vegetables and berries as well as food component servings that reflect the nutrition dementia evidence. | Other | MIND DIET intervention |
| Behavioral Usual Care Diet InterventionThe Usual Care diet is comprised of both westernized (e.g. Steak, Mac n Cheese) and healthy ( veggie chili) food components | Other | Usual care diet intervention |
Primary outcome
Change in global cognitive score
Time frame: 3-years
3-year change in global cognitive score. The global cognitive score is a composite score, based on the average of z scores of the 19 individual tests scores, with a mean of 0 and standard deviation of 1. Higher scores reflect high global cognitive function.
2 secondary outcomes
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)
Time frame: 3-years
Change in 5 individual cognitive domains
Time frame: 3-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 33835152Halloway S, Dhana K, Desai P, Agarwal P, Holland T, Aggarwal NT, Evers J, Sacks FM, Carey VJ, Barnes LL. Free-Living Standing Activity as Assessed by Seismic Accelerometers and Cognitive Function in Community-Dwelling Older Adults: The MIND Trial. J Gerontol A Biol Sci Med Sci. 2021 Oct 13;76(11):1981-1987. doi: 10.1093/gerona/glab106.
- Background: PubMed 41044190Dhana K, Aggarwal NT, Voigt RM, Ventrelle J, Rajan KB, Kaddurah-Daouk R, Marcovina SM, Liu X, Agarwal P, Tangney C, Arfanakis K, Sacks FM, Barnes LL. Effect of weight loss through dietary interventions on cardiometabolic health in older adults. Int J Obes (Lond). 2025 Dec;49(12):2503-2510. doi: 10.1038/s41366-025-01902-6. Epub 2025 Oct 3.
- Background: PubMed 34527222Liu X, Dhana K, Furtado JD, Agarwal P, Aggarwal NT, Tangney C, Laranjo N, Carey V, Barnes LL, Sacks FM. Higher circulating alpha-carotene was associated with better cognitive function: an evaluation among the MIND trial participants. J Nutr Sci. 2021 Aug 16;10:e64. doi: 10.1017/jns.2021.56. eCollection 2021.
- Background: PubMed 33434704Liu X, Morris MC, Dhana K, Ventrelle J, Johnson K, Bishop L, Hollings CS, Boulin A, Laranjo N, Stubbs BJ, Reilly X, Carey VJ, Wang Y, Furtado JD, Marcovina SM, Tangney C, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline. Contemp Clin Trials. 2021 Mar;102:106270. doi: 10.1016/j.cct.2021.106270. Epub 2021 Jan 9.
- Background: PubMed 37466280Barnes LL, Dhana K, Liu X, Carey VJ, Ventrelle J, Johnson K, Hollings CS, Bishop L, Laranjo N, Stubbs BJ, Reilly X, Agarwal P, Zhang S, Grodstein F, Tangney CC, Holland TM, Aggarwal NT, Arfanakis K, Morris MC, Sacks FM. Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons. N Engl J Med. 2023 Aug 17;389(7):602-611. doi: 10.1056/NEJMoa2302368. Epub 2023 Jul 18.
- Background: PubMed 42457038Dhana K, Aggarwal NT, Ventrelle J, Voigt RM, Liu X, Agarwal P, Tangney C, Arfanakis K, Sacks FM, Barnes LL. Adherence to the Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet and longitudinal changes in global cognition: a post hoc analysis of the MIND trial. Am J Clin Nutr. 2026 Jul 15;124(3):101433. doi: 10.1016/j.ajcnut.2026.101433. Online ahead of print.
- Background: PubMed 42033408Dhana K, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Dietary intervention and cognition across Alzheimer's disease biomarker levels: The MIND clinical trial. J Alzheimers Dis. 2026 Jun;111(3):1301-1308. doi: 10.1177/13872877261442856. Epub 2026 Apr 25.
- Background: PubMed 26086182Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15.
- Background: PubMed 25681666Morris MC, Tangney CC, Wang Y, Sacks FM, Bennett DA, Aggarwal NT. MIND diet associated with reduced incidence of Alzheimer's disease. Alzheimers Dement. 2015 Sep;11(9):1007-14. doi: 10.1016/j.jalz.2014.11.009. Epub 2015 Feb 11.
- Results publication: PubMed 41052713Ventrelle J, Lukaszewicz B, Claysen M, Setia B, Aggarwal NT, Tangney CC; NOURISH Study Team. A framework for monitoring intervention fidelity: The NOURISH trial. Contemp Clin Trials. 2025 Nov;158:108104. doi: 10.1016/j.cct.2025.108104. Epub 2025 Oct 4.
- Results publication: PubMed 31686099Cherian L, Wang Y, Fakuda K, Leurgans S, Aggarwal N, Morris M. Mediterranean-Dash Intervention for Neurodegenerative Delay (MIND) Diet Slows Cognitive Decline After Stroke. J Prev Alzheimers Dis. 2019;6(4):267-273. doi: 10.14283/jpad.2019.28.
- Individual participant dataSharing planned: Yes. Electronic data will be made available after trial completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neelum T Aggarwal, MD. principal investigator
Rush University Medical Center
Christy Tangney, PhD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Dietary intervention ( MIND Diet) in people with Cognitive Decline and Dementia, Vascular, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in global cognitive score (time frame: 3-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04337255, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.