Cognitive DeclineMINDNCT02817074
MIND Diet Intervention and Cognitive Decline
A study testing MIND Diet and Mild Weight Loss in people with Cognitive Decline and Dementia, run by Rush University Medical Center at 2 sites in United States.
Trial summary
Phase III randomized controlled trial designed to test the effects of a 3-year intervention of the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) on cognitive decline and brain neurodegeneration among 600 individuals 65+ years without cognitive impairment who are overweight and have suboptimal… Read more about this study
- Who is it for?
- Ages 65 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Dementia, Alzheimer Disease
- What is being tested?
- MIND Diet and Mild Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 604 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 to 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- family history of dementia
- BMI >=25
- suboptimal diet
Who cannot join
- heavy alcohol use
- severe illness
- cognitively impaired
- psychiatric illness
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Harvard School of Public Health
Boston, Massachusetts, 02115
Rush University
Chicago, Illinois, 60612
About this study
Official title: MIND Diet Intervention to Prevent Alzheimer's Disease
Phase III randomized controlled trial designed to test the effects of a 3-year intervention of the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) on cognitive decline and brain neurodegeneration among 600 individuals 65+ years without cognitive impairment who are overweight and have suboptimal diets.
Read the detailed description
Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) is a Phase III randomized controlled trial designed to test the effects of a 3-year intervention of a hybrid of the Mediterranean and DASH diets, called MIND, on cognitive decline among 600 individuals 65+ years without cognitive impairment who are overweight and have suboptimal diets. The proposed 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. The trial will employ a parallel group design comparing the effects on cognitive outcomes of the MIND intervention diet plus mild caloric restriction for weight loss to the control diet, usual diet with mild caloric restriction for weight loss. Biological effects of the MIND diet will be assessed by measurement of brain macro- and micro-structural integrity in 300 randomly selected participants. Other biochemical markers will be assessed in the entire cohort of 600 participants, including: plasma Abeta 42/Abeta 40, brain-derived neurotrophic factor (BDNF) and plasma markers of oxidative stress and inflammation. In addition, 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 two clinical sites, one in Chicago (Rush University) and one in Boston (Harvard University), and centralized laboratories for data coordinating and analyses (Brigham \& Women's Hospital), neuroimaging analyses (Rush University), and specialized laboratories for tissue biochemical analyses.
- Conditions
- Cognitive Decline, Dementia, Alzheimer Disease, Vascular Dementia
- Being tested
- MIND Diet, Mild Weight Loss
- Medical subject headings
- Cognitive Dysfunction, Dementia, Alzheimer Disease, Dementia, Vascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIND DietBehavioural
3-year dietary counseling to adhere to the MIND diet and for mild weight loss
Mild Weight LossBehavioural
3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss
| Study group | Role | What they receive |
|---|---|---|
| MIND Diet +Weight loss | Active comparator | 3-year intervention of dietary counseling to adhere to the MIND diet plus reduce calorie intake by 250 kcal /day for mild weight loss Receives: Behavioral: MIND Diet; Behavioral: Mild Weight Loss |
| Usual Diet + Weight Loss | Placebo comparator | 3-year intervention of usual diet + counseling to reduce calorie intake by 250 kcal/day for mild weight loss Receives: Behavioral: Mild Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in global cognitive function (composite score)
Global cognitive function assessment is based on a battery of 12 cognitive tests [1. Word list Memory; 2. Word List Recall; 3. Word List Recognition; 4. Logical Memory (East Boston Story Immediate Recall); 5. Logical Memory (East Boston Story Delayed Recall); 6. Verbal Fluency; 7. Multilingual Naming Test; 8. Trail A; 9. Trail B; 10. Flanker Inhibitory Control; 11. Oral Symbol Digit Modalities Test; and 12. Pattern Comparison. Individual test scores will be summarized by calculating the z-score for each test based on the mean and standard deviation of the sample distribution - averaging z-scores across tests will yield a composite score for global cognitive function. Cognitive function will be assessed at the baseline, 6, 12, 24, and 36 months to determine the time-course of cognitive change.
Measured: 3 years
Change in specific cognitive domains
Change in specific cognitive domains: episodic memory, semantic memory, perceptual speed, and executive function
Measured: 3 years
Secondary outcomes (1)
Change in brain MRI total brain /intracranial volume (cubic centimeters) and hippocampal/intracranial volume (cubic centimeters)
Changes in brain MRI-derived normalized measures of total brain volume (cubic centimeters) and hippocampal volume (cubic centimeters) and white/gray matter, segmented gray matter regions, white matter lesions, and thickness of segmented cortical regions.
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 posted29 Jun 2016 (estimated)
- Study startJan 2017
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 604 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Brigham and Women's Hospital, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lisa L. Barnes, PhD, Rush University Medical Center
- Investigators
- Lisa L Barnes, Ph.D., Principal investigator, Rush University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02817074
- Sponsor's protocol ID
- R01AG051641
- Other IDs
- 1R01AG052583-01
- Acronym
- MIND
- Status last verified
- Mar 2022
- First submitted
- 23 Jun 2016
- Last updated
- 23 Mar 2022
- 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
Morris 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 25681666Dhana 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 42033408Halloway S, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL, Dhana K. Effect modifiers of the MIND diet for cognition in older adults: The MIND diet trial. Alzheimers Dement. 2025 Oct;21(10):e70731. doi: 10.1002/alz.70731.
PubMed 41058007Dhana 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, Sacks FM, Beck T, Tangney CC, Willett WC, Yassine H, Dhana K, Aggarwal NT, Rajan KB, Barnes LL. Apolipoprotein E epsilon4-dependent associations between carotenoids and cognitive decline: Findings from the MIND (Mediterranean-DASH Intervention for Neurodegenerative delay) randomized controlled trial. Am J Clin Nutr. 2025 Nov;122(5):1289-1297. doi: 10.1016/j.ajcnut.2025.08.012. Epub 2025 Aug 27.
PubMed 40876538Barnes 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 37466280Liu 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 34527222Lefevre-Arbogast S, Dhana K, Aggarwal NT, Zhang S, Agarwal P, Liu X, Laranjo N, Carey V, Sacks F, Barnes LL, Arfanakis K. Vitamin D Intake and Brain Cortical Thickness in Community-Dwelling Overweight Older Adults: A Cross-Sectional Study. J Nutr. 2021 Sep 4;151(9):2760-2767. doi: 10.1093/jn/nxab168.
PubMed 34113981Halloway 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 33835152Liu 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 33434704
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIND Diet Intervention to Prevent Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT02817074
- Acronym / sponsor ID
- MIND / R01AG051641
- Conditions
- Cognitive Decline, Dementia, Alzheimer Disease, Vascular Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 604 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Harvard School of Public Health (HSPH), Brigham and Women's Hospital, National Institute on Aging (NIA)
- Study start
- Jan 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 29 Jun 2016 (estimated)
- 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.
Phase III randomized controlled trial designed to test the effects of a 3-year intervention of the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) on cognitive decline and brain neurodegeneration among 600 individuals 65+ years without cognitive impairment who are overweight and have suboptimal diets.
Detailed description
Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) is a Phase III randomized controlled trial designed to test the effects of a 3-year intervention of a hybrid of the Mediterranean and DASH diets, called MIND, on cognitive decline among 600 individuals 65+ years without cognitive impairment who are overweight and have suboptimal diets. The proposed 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. The trial will employ a parallel group design comparing the effects on cognitive outcomes of the MIND intervention diet plus mild caloric restriction for weight loss to the control diet, usual diet with mild caloric restriction for weight loss. Biological effects of the MIND diet will be assessed by measurement of brain macro- and micro-structural integrity in 300 randomly selected participants. Other biochemical markers will be assessed in the entire cohort of 600 participants, including: plasma Abeta 42/Abeta 40, brain-derived neurotrophic factor (BDNF) and plasma markers of oxidative stress and inflammation. In addition, 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 two clinical sites, one in Chicago (Rush University) and one in Boston (Harvard University), and centralized laboratories for data coordinating and analyses (Brigham \& Women's Hospital), neuroimaging analyses (Rush University), and specialized laboratories for tissue biochemical analyses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIND Diet +Weight loss | Active comparator | Behavioral: MIND Diet, Behavioral: Mild Weight Loss3-year intervention of dietary counseling to adhere to the MIND diet plus reduce calorie intake by 250 kcal /day for mild weight loss |
| Usual Diet + Weight Loss | Placebo comparator | Behavioral: Mild Weight Loss3-year intervention of usual diet + counseling to reduce calorie intake by 250 kcal/day for mild weight loss |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- family history of dementia
- BMI >=25
- suboptimal diet
Key exclusion criteria (4 listed)
- heavy alcohol use
- severe illness
- cognitively impaired
- psychiatric illness
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 |
|---|---|---|
| MIND Diet3-year dietary counseling to adhere to the MIND diet and for mild weight loss | Behavioural | MIND Diet +Weight loss |
| Mild Weight Loss3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss | Behavioural | MIND Diet +Weight loss, Usual Diet + Weight Loss |
Primary outcome
Change in global cognitive function (composite score)
Time frame: 3 years
Global cognitive function assessment is based on a battery of 12 cognitive tests [1. Word list Memory; 2. Word List Recall; 3. Word List Recognition; 4. Logical Memory (East Boston Story Immediate Recall); 5. Logical Memory (East Boston Story Delayed Recall); 6. Verbal Fluency; 7. Multilingual Naming Test; 8. Trail A; 9. Trail B; 10. Flanker Inhibitory Control; 11. Oral Symbol Digit Modalities Test; and 12. Pattern Comparison. Individual test scores will be summarized by calculating the z-score for each test based on the mean and standard deviation of the sample distribution - averaging z-scores across tests will yield a composite score for global cognitive function. Cognitive function will be assessed at the baseline, 6, 12, 24, and 36 months to determine the time-course of cognitive change.
Change in specific cognitive domains
Time frame: 3 years
Change in specific cognitive domains: episodic memory, semantic memory, perceptual speed, and executive function
1 secondary outcome
Change in brain MRI total brain /intracranial volume (cubic centimeters) and hippocampal/intracranial volume (cubic centimeters)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- 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.
- Derived from this study: 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.
- Derived from this study: 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.
- Derived from this study: PubMed 41058007Halloway S, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL, Dhana K. Effect modifiers of the MIND diet for cognition in older adults: The MIND diet trial. Alzheimers Dement. 2025 Oct;21(10):e70731. doi: 10.1002/alz.70731.
- Derived from this study: 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.
- Derived from this study: PubMed 40876538Liu X, Sacks FM, Beck T, Tangney CC, Willett WC, Yassine H, Dhana K, Aggarwal NT, Rajan KB, Barnes LL. Apolipoprotein E epsilon4-dependent associations between carotenoids and cognitive decline: Findings from the MIND (Mediterranean-DASH Intervention for Neurodegenerative delay) randomized controlled trial. Am J Clin Nutr. 2025 Nov;122(5):1289-1297. doi: 10.1016/j.ajcnut.2025.08.012. Epub 2025 Aug 27.
- Derived from this study: 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.
- Derived from this study: 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.
- Derived from this study: PubMed 34113981Lefevre-Arbogast S, Dhana K, Aggarwal NT, Zhang S, Agarwal P, Liu X, Laranjo N, Carey V, Sacks F, Barnes LL, Arfanakis K. Vitamin D Intake and Brain Cortical Thickness in Community-Dwelling Overweight Older Adults: A Cross-Sectional Study. J Nutr. 2021 Sep 4;151(9):2760-2767. doi: 10.1093/jn/nxab168.
- Derived from this study: 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.
- Derived from this study: 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.
- Individual participant dataSharing planned: Yes. Electronic data will be made available after trial completion
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EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
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.
Lisa L Barnes, Ph.D. principal investigator
Rush University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIND Diet and Mild Weight Loss in people with Cognitive Decline and Dementia, run by Rush University Medical Center at 2 sites 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 function (composite score) (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT02817074, which also lists 12 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 23 Mar 2022.