DementiaINSPIRE -FaithNCT06741865
The INSPIRE -Faith Study: Intervention Strategies for Preserving Intellectual Resilience and Engagement
A study testing Lifestyle Intervention and Standard Health Education in people with Dementia, run by Healthy Minds Initiative at 1 site in United States.
Trial summary
The INSPIRE-Faith Study, initiated by the Healthy Minds Initiative, is a community-based research project aimed at demonstrating the impact of lifestyle factors on cognitive health and the prevention of dementia. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- Lifestyle Intervention and Standard Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2025to 1 Dec 2028
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: Participants must be 55 years of age or older.
- Ethnicity: Focused on African American individuals, but not exclusive.
- Cognitive Status: Participants must have normal cognitive status, mild cognitive impairment (MCI), or subjective cognitive impairment (SCI).
- Language: Participants must be fluent in English.
- Location: Must reside in the Crenshaw, California area or* be able to attend study-related activities in this location. *online access is available for those not in this area.
- Willingness to Participate: Participants must be willing to adhere to the study protocol, including attending assessments, participating in interventions, and completing questionnaires.
Who cannot join
- Cognitive Decline: Diagnosis of dementia or severe cognitive impairment that would interfere with the ability to participate in the study.
- Physical Limitations: Any physical or medical condition that would preclude participation in the lifestyle interventions (e.g., severe mobility issues).
- Recent Cancer Diagnosis: Diagnosis of cancer within the last three years, excluding stable cases of basal cell or squamous cell carcinoma of the skin, or stable prostate cancer.
- Pregnancy: Current pregnancy or planning to become pregnant during the study period.
- Mental Health: Diagnosis of severe psychiatric disorders such as schizophrenia or bipolar disorder that might interfere with participation.
- Substance Abuse: Current substance abuse or dependency that could impact participation.
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- Hearing Impairment: Uncorrected hearing loss that would limit the ability to communicate and participate in the study.
- Non-English Speaking: Inability to participate in English-language oral and written cognitive assessments.
- Participation in Another Study: Currently enrolled in another clinical trial that could interfere with the INSPIRE Study.
- Life expectancy less than 3 years
- Unwillingness to share medical and laboratory information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Crenshaw Christian Center
Los Angeles, California, 90044
Brenda Bennett, 323-758-3777, bbennett@Faithdome.org
Dean Sherzai, MD, PhD
About this study
Official title: Intervention Strategies for Preserving Intellectual Resilience and Engagement
The INSPIRE-Faith Study, initiated by the Healthy Minds Initiative, is a community-based research project aimed at demonstrating the impact of lifestyle factors on cognitive health and the prevention of dementia. Conducted in collaboration with the American College of Lifestyle Medicine, Charles Drew University, UCLA, Stanford University and Crenshaw Christian Center, this study focuses on all communities that are affected by lifestyle-dependent diseases. The study involves 2,000 participants aged 55 and older and aims to implement targeted community relevant interventions to enhance cognitive function and overall brain health.
Read the detailed description
The INSPIRE-Faith Study, led by the Healthy Minds Initiative, is a groundbreaking community-based research project aimed at exploring the relationship between lifestyle factors and cognitive health, with an emphasis on nutrition and dietary intervention, to prevent dementia and cognitive impairment in communities. This study will take start in South Los Angeles, California, a region characterized by the prevalence of lifestyle-dependent diseases but will expand into all of California.
The study, slated to begin in January/February 2025, will involve 2,000 participants aged 55 and older, recruited through community outreach, health education programs, and referrals from local healthcare providers. Participants will undergo a comprehensive initial assessment, including evaluations of medical history, cognitive function, lifestyle habits, and access to health resources.
Participants will be randomized into two groups: an intervention group and a control group. The intervention group will receive personalized guidance from health coaches, participate in an online community forum designed to teach about nutrition and lifestyle risk factor management, and have access to tailored exercise programs, educational materials, and other resources designed to promote cognitive health. The control group will receive standard-of-care educational material and monthly communications aimed at maintaining or improving health. Both groups will undergo baseline assessments and periodic evaluations throughout the study to measure the impact of the interventions on cognitive health.
The Inspire-Faith Study employs a randomized controlled crossover design to promote equity, maximize participant benefit, and enhance retention. Participants will be randomized to either the Guided Lifestyle Intervention Group or the Independent (Standard Health Education) Group for the first 6 months. At the 6-month midpoint, study arms will cross over, such that participants initially assigned to the control condition will receive the guided intervention, and participants initially receiving the guided intervention will transition to the independent condition.
The study is designed to leverage community partnerships with organizations such as the American College of Lifestyle Medicine, Charles Drew University, UCLA, Stanford University and Crenshaw Christian Center. These partnerships provide the necessary infrastructure, expertise, and community trust to ensure the study's success.
The INSPIRE Study's primary goal is to demonstrate how targeted community relevant lifestyle interventions can reduce the risk of cognitive decline in all populations that are vulnerable to such outcomes. By addressing factors such as diet, physical activity, stress management, and social engagement, and management of vascular risk factors, the study aims to create a model for improving brain health that can be replicated in all communities.
The study's findings will not only contribute to the scientific understanding of lifestyle-related cognitive health but also have the potential to inform public health strategies and policy decisions aimed at improving access to health resources and support. The long-term vision is to establish the Healthy Minds Initiative as a leader in brain health for all, with the INSPIRE Study serving as a blueprint for future community interventions.
- Conditions
- Dementia
- Being tested
- Lifestyle Intervention, Standard Health Education
- Keywords
- Dementia, Alzheimer
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
This arm involves interventions like health coaching, dietary changes, exercise programs, and other lifestyle modifications.
Standard Health EducationOther
Participants in the Standard of Care Arm will receive basic educational materials focused on general cognitive and physical health maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | This arm involves an active intervention with health coaching and lifestyle changes. Receives: Behavioral: Lifestyle Intervention |
| Standard Health Education | Active comparator | This arm receives a standard educational approach without the intensive intervention. Receives: Other: Standard Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cognitive Function
Change in global composite score from baseline, as measured by the TABCAT (Tablet-based Cognitive Assessment Tool) composite score, at the designated endpoint (e.g., 6 months, 1 year, and 3 years). This composite score reflects core domains of cognition-including memory, executive function, language, and processing speed-captured through standardized TABCAT assessments.
Measured: 6 months, 1 year and 3 years
Secondary outcomes (1)
Adherence to Lifestyle Interventions
Measure adherence to prescribed diet and exercise changes through self-reported questionnaires and logs maintained by health coaches.
Measured: Continuous, with key evaluations at 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Jun 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies 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
- Model description
- The INSPIRE Study is a randomized controlled trial (RCT) with 2,000 participants aged 55 and older. Participants will be randomly assigned to either an intervention group, receiving a personalized, lifestyle-based program with health coaching, or a control group, receiving standard health education materials. Both groups will undergo baseline and follow-up assessments, including cognitive tests and lifestyle evaluations. The study emphasizes community engagement and lifestyle interventions, aiming to provide insights into the impact of lifestyle changes on cognitive health and to inform public health strategies for dementia prevention in all populations.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Healthy Minds Initiative
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Lifestyle Medicine, Charles Drew University of Medicine and Science, University of California, Los Angeles, Stanford University
- Responsible party
- Sponsor
- Investigators
- Dean Sherzai, MD, PhD, Principal investigator, Healthy Minds Initiative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741865
- Sponsor's protocol ID
- 20211795
- Acronym
- INSPIRE -Faith
- Status last verified
- May 2026
- First submitted
- 12 Aug 2024
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Livingston G, Huntley J, Liu KY, Costafreda SG, Selbaek G, Alladi S, Ames D, Banerjee S, Burns A, Brayne C, Fox NC, Ferri CP, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Nakasujja N, Rockwood K, Samus Q, Shirai K, Singh-Manoux A, Schneider LS, Walsh S, Yao Y, Sommerlad A, Mukadam N. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet. 2024 Aug 10;404(10452):572-628. doi: 10.1016/S0140-6736(24)01296-0. Epub 2024 Jul 31. No abstract available.
PubMed 39096926Schippinger WM, Pichler G. [Prevention of dementia]. Z Gerontol Geriatr. 2023 May;56(3):227-234. doi: 10.1007/s00391-023-02175-2. Epub 2023 Apr 25. German.
PubMed 37097299Willroth EC, Pfund GN, Rule PD, Hill PL, John A, Kyle K, Hassenstab J, James BD. A review of the literature on wellbeing and modifiable dementia risk factors. Ageing Res Rev. 2024 Aug;99:102380. doi: 10.1016/j.arr.2024.102380. Epub 2024 Jun 14.
PubMed 38880341Dominguez LJ, Veronese N, Vernuccio L, Catanese G, Inzerillo F, Salemi G, Barbagallo M. Nutrition, Physical Activity, and Other Lifestyle Factors in the Prevention of Cognitive Decline and Dementia. Nutrients. 2021 Nov 15;13(11):4080. doi: 10.3390/nu13114080.
PubMed 34836334Ward DD, Ranson JM, Wallace LMK, Llewellyn DJ, Rockwood K. Frailty, lifestyle, genetics and dementia risk. J Neurol Neurosurg Psychiatry. 2022 Apr;93(4):343-350. doi: 10.1136/jnnp-2021-327396. Epub 2021 Dec 21.
PubMed 34933996Dhana K, Evans DA, Rajan KB, Bennett DA, Morris MC. Healthy lifestyle and the risk of Alzheimer dementia: Findings from 2 longitudinal studies. Neurology. 2020 Jul 28;95(4):e374-e383. doi: 10.1212/WNL.0000000000009816. Epub 2020 Jun 17.
PubMed 32554763Low LF, Barcenilla-Wong A, Fitzpatrick M, Swaffer K, Brodaty H, Hancock N, McLoughlin J, Naismith S. Dementia lifestyle coach pilot program. Australas J Ageing. 2023 Sep;42(3):508-516. doi: 10.1111/ajag.13169. Epub 2022 Dec 22.
PubMed 36546406Aranda MP, Kremer IN, Hinton L, Zissimopoulos J, Whitmer RA, Hummel CH, Trejo L, Fabius C. Impact of dementia: Health disparities, population trends, care interventions, and economic costs. J Am Geriatr Soc. 2021 Jul;69(7):1774-1783. doi: 10.1111/jgs.17345.
PubMed 34245588Liu C, Murchland AR, VanderWeele TJ, Blacker D. Eliminating racial disparities in dementia risk by equalizing education quality: A sensitivity analysis. Soc Sci Med. 2022 Nov;312:115347. doi: 10.1016/j.socscimed.2022.115347. Epub 2022 Sep 12.
PubMed 36162365Lennon JC, Aita SL, Bene VAD, Rhoads T, Resch ZJ, Eloi JM, Walker KA. Black and White individuals differ in dementia prevalence, risk factors, and symptomatic presentation. Alzheimers Dement. 2022 Aug;18(8):1461-1471. doi: 10.1002/alz.12509. Epub 2021 Dec 2.
PubMed 34854531Sherzai D, Sherzai A, Lui K, Pan D, Chiou D, Bazargan M, Shaheen M. The Association Between Diabetes and Dementia Among Elderly Individuals: A Nationwide Inpatient Sample Analysis. J Geriatr Psychiatry Neurol. 2016 May;29(3):120-5. doi: 10.1177/0891988715627016. Epub 2016 Feb 9.
PubMed 26862150Sherzai D, Sherzai A. Preventing Alzheimer's: Our Most Urgent Health Care Priority. Am J Lifestyle Med. 2019 May 9;13(5):451-461. doi: 10.1177/1559827619843465. eCollection 2019 Sep-Oct.
PubMed 31523210Morris 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 26086182Barnes 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 37466280Morris 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 25681666
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Strategies for Preserving Intellectual Resilience and Engagement
- ClinicalTrials.gov ID
- NCT06741865
- Acronym / sponsor ID
- INSPIRE -Faith / 20211795
- Conditions
- Dementia
- Keywords
- Dementia, Alzheimer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Healthy Minds InitiativeUniversity, hospital or other
- Collaborators
- American College of Lifestyle Medicine, Charles Drew University of Medicine and Science, University of California, Los Angeles, Stanford University
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 19 Dec 2024 (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.
The INSPIRE-Faith Study, initiated by the Healthy Minds Initiative, is a community-based research project aimed at demonstrating the impact of lifestyle factors on cognitive health and the prevention of dementia. Conducted in collaboration with the American College of Lifestyle Medicine, Charles Drew University, UCLA, Stanford University and Crenshaw Christian Center, this study focuses on all communities that are affected by lifestyle-dependent diseases. The study involves 2,000 participants aged 55 and older and aims to implement targeted community relevant interventions to enhance cognitive function and overall brain health.
Detailed description
The INSPIRE-Faith Study, led by the Healthy Minds Initiative, is a groundbreaking community-based research project aimed at exploring the relationship between lifestyle factors and cognitive health, with an emphasis on nutrition and dietary intervention, to prevent dementia and cognitive impairment in communities. This study will take start in South Los Angeles, California, a region characterized by the prevalence of lifestyle-dependent diseases but will expand into all of California.
The study, slated to begin in January/February 2025, will involve 2,000 participants aged 55 and older, recruited through community outreach, health education programs, and referrals from local healthcare providers. Participants will undergo a comprehensive initial assessment, including evaluations of medical history, cognitive function, lifestyle habits, and access to health resources.
Participants will be randomized into two groups: an intervention group and a control group. The intervention group will receive personalized guidance from health coaches, participate in an online community forum designed to teach about nutrition and lifestyle risk factor management, and have access to tailored exercise programs, educational materials, and other resources designed to promote cognitive health. The control group will receive standard-of-care educational material and monthly communications aimed at maintaining or improving health. Both groups will undergo baseline assessments and periodic evaluations throughout the study to measure the impact of the interventions on cognitive health.
The Inspire-Faith Study employs a randomized controlled crossover design to promote equity, maximize participant benefit, and enhance retention. Participants will be randomized to either the Guided Lifestyle Intervention Group or the Independent (Standard Health Education) Group for the first 6 months. At the 6-month midpoint, study arms will cross over, such that participants initially assigned to the control condition will receive the guided intervention, and participants initially receiving the guided intervention will transition to the independent condition.
The study is designed to leverage community partnerships with organizations such as the American College of Lifestyle Medicine, Charles Drew University, UCLA, Stanford University and Crenshaw Christian Center. These partnerships provide the necessary infrastructure, expertise, and community trust to ensure the study's success.
The INSPIRE Study's primary goal is to demonstrate how targeted community relevant lifestyle interventions can reduce the risk of cognitive decline in all populations that are vulnerable to such outcomes. By addressing factors such as diet, physical activity, stress management, and social engagement, and management of vascular risk factors, the study aims to create a model for improving brain health that can be replicated in all communities.
The study's findings will not only contribute to the scientific understanding of lifestyle-related cognitive health but also have the potential to inform public health strategies and policy decisions aimed at improving access to health resources and support. The long-term vision is to establish the Healthy Minds Initiative as a leader in brain health for all, with the INSPIRE Study serving as a blueprint for future community interventions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- The INSPIRE Study is a randomized controlled trial (RCT) with 2,000 participants aged 55 and older. Participants will be randomly assigned to either an intervention group, receiving a personalized, lifestyle-based program with health coaching, or a control group, receiving standard health education materials. Both groups will undergo baseline and follow-up assessments, including cognitive tests and lifestyle evaluations. The study emphasizes community engagement and lifestyle interventions, aiming to provide insights into the impact of lifestyle changes on cognitive health and to inform public health strategies for dementia prevention in all populations.
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Lifestyle InterventionThis arm involves an active intervention with health coaching and lifestyle changes. |
| Standard Health Education | Active comparator | Other: Standard Health EducationThis arm receives a standard educational approach without the intensive intervention. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: Participants must be 55 years of age or older.
- Ethnicity: Focused on African American individuals, but not exclusive.
- Cognitive Status: Participants must have normal cognitive status, mild cognitive impairment (MCI), or subjective cognitive impairment (SCI).
- Language: Participants must be fluent in English.
- Location: Must reside in the Crenshaw, California area or* be able to attend study-related activities in this location. *online access is available for those not in this area.
Key exclusion criteria (11 listed)
- Cognitive Decline: Diagnosis of dementia or severe cognitive impairment that would interfere with the ability to participate in the study.
- Physical Limitations: Any physical or medical condition that would preclude participation in the lifestyle interventions (e.g., severe mobility issues).
- Recent Cancer Diagnosis: Diagnosis of cancer within the last three years, excluding stable cases of basal cell or squamous cell carcinoma of the skin, or stable prostate cancer.
- Pregnancy: Current pregnancy or planning to become pregnant during the study period.
- Mental Health: Diagnosis of severe psychiatric disorders such as schizophrenia or bipolar disorder that might interfere with participation.
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 |
|---|---|---|
| Lifestyle InterventionThis arm involves interventions like health coaching, dietary changes, exercise programs, and other lifestyle modifications. | Behavioural | Lifestyle Intervention |
| Standard Health EducationParticipants in the Standard of Care Arm will receive basic educational materials focused on general cognitive and physical health maintenance. | Other | Standard Health Education |
Primary outcome
Change in Cognitive Function
Time frame: 6 months, 1 year and 3 years
Change in global composite score from baseline, as measured by the TABCAT (Tablet-based Cognitive Assessment Tool) composite score, at the designated endpoint (e.g., 6 months, 1 year, and 3 years). This composite score reflects core domains of cognition-including memory, executive function, language, and processing speed-captured through standardized TABCAT assessments.
1 secondary outcome
Adherence to Lifestyle Interventions
Time frame: Continuous, with key evaluations at 6 months and 12 months.
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 28 May 2026.
- Background: PubMed 39096926Livingston G, Huntley J, Liu KY, Costafreda SG, Selbaek G, Alladi S, Ames D, Banerjee S, Burns A, Brayne C, Fox NC, Ferri CP, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Nakasujja N, Rockwood K, Samus Q, Shirai K, Singh-Manoux A, Schneider LS, Walsh S, Yao Y, Sommerlad A, Mukadam N. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet. 2024 Aug 10;404(10452):572-628. doi: 10.1016/S0140-6736(24)01296-0. Epub 2024 Jul 31. No abstract available.
- Background: PubMed 37097299Schippinger WM, Pichler G. [Prevention of dementia]. Z Gerontol Geriatr. 2023 May;56(3):227-234. doi: 10.1007/s00391-023-02175-2. Epub 2023 Apr 25. German.
- Background: PubMed 38880341Willroth EC, Pfund GN, Rule PD, Hill PL, John A, Kyle K, Hassenstab J, James BD. A review of the literature on wellbeing and modifiable dementia risk factors. Ageing Res Rev. 2024 Aug;99:102380. doi: 10.1016/j.arr.2024.102380. Epub 2024 Jun 14.
- Background: PubMed 34836334Dominguez LJ, Veronese N, Vernuccio L, Catanese G, Inzerillo F, Salemi G, Barbagallo M. Nutrition, Physical Activity, and Other Lifestyle Factors in the Prevention of Cognitive Decline and Dementia. Nutrients. 2021 Nov 15;13(11):4080. doi: 10.3390/nu13114080.
- Background: PubMed 34933996Ward DD, Ranson JM, Wallace LMK, Llewellyn DJ, Rockwood K. Frailty, lifestyle, genetics and dementia risk. J Neurol Neurosurg Psychiatry. 2022 Apr;93(4):343-350. doi: 10.1136/jnnp-2021-327396. Epub 2021 Dec 21.
- Background: PubMed 32554763Dhana K, Evans DA, Rajan KB, Bennett DA, Morris MC. Healthy lifestyle and the risk of Alzheimer dementia: Findings from 2 longitudinal studies. Neurology. 2020 Jul 28;95(4):e374-e383. doi: 10.1212/WNL.0000000000009816. Epub 2020 Jun 17.
- Background: PubMed 36546406Low LF, Barcenilla-Wong A, Fitzpatrick M, Swaffer K, Brodaty H, Hancock N, McLoughlin J, Naismith S. Dementia lifestyle coach pilot program. Australas J Ageing. 2023 Sep;42(3):508-516. doi: 10.1111/ajag.13169. Epub 2022 Dec 22.
- Background: PubMed 34245588Aranda MP, Kremer IN, Hinton L, Zissimopoulos J, Whitmer RA, Hummel CH, Trejo L, Fabius C. Impact of dementia: Health disparities, population trends, care interventions, and economic costs. J Am Geriatr Soc. 2021 Jul;69(7):1774-1783. doi: 10.1111/jgs.17345.
- Background: PubMed 36162365Liu C, Murchland AR, VanderWeele TJ, Blacker D. Eliminating racial disparities in dementia risk by equalizing education quality: A sensitivity analysis. Soc Sci Med. 2022 Nov;312:115347. doi: 10.1016/j.socscimed.2022.115347. Epub 2022 Sep 12.
- Background: PubMed 34854531Lennon JC, Aita SL, Bene VAD, Rhoads T, Resch ZJ, Eloi JM, Walker KA. Black and White individuals differ in dementia prevalence, risk factors, and symptomatic presentation. Alzheimers Dement. 2022 Aug;18(8):1461-1471. doi: 10.1002/alz.12509. Epub 2021 Dec 2.
- Background: PubMed 26862150Sherzai D, Sherzai A, Lui K, Pan D, Chiou D, Bazargan M, Shaheen M. The Association Between Diabetes and Dementia Among Elderly Individuals: A Nationwide Inpatient Sample Analysis. J Geriatr Psychiatry Neurol. 2016 May;29(3):120-5. doi: 10.1177/0891988715627016. Epub 2016 Feb 9.
- Background: PubMed 31523210Sherzai D, Sherzai A. Preventing Alzheimer's: Our Most Urgent Health Care Priority. Am J Lifestyle Med. 2019 May 9;13(5):451-461. doi: 10.1177/1559827619843465. eCollection 2019 Sep-Oct.
- Individual participant dataSharing planned: No
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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.
Dean Sherzai, MD, PhD principal investigator
Healthy Minds Initiative
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Intervention and Standard Health Education in people with Dementia, run by Healthy Minds Initiative 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 11 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: looking for participants now, as of the sponsor's last update on 28 May 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. 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?
Contact Dean Sherzai, MD, PhD (949-383-6729, dean@healthymindsinitiative.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function (time frame: 6 months, 1 year and 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 NCT06741865, which also lists 16 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 28 May 2026.