The INSPIRE Study: Intervention Strategies for Preserving Intellectual Resilience and Engagement

NCT06741865 | Recruiting DMC

• 1 other identifier: 20211795
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The INSPIRE 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 African American communities that are disproportionately affected by lifestyle-dependent diseases. The study involves 2,000 participants aged 55 and older and aims to directly address these disparities by implementing targeted interventions to enhance cognitive function and overall brain health.

Conditions

Dementia

Keywords

Dementia; Alzheimer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months, 1 year and 3 years

Secondary Outcomes (1)

• Adherence to Lifestyle Interventions

  Continuous, with key evaluations at 6 months and 12 months.

Other Outcomes (5)

• Change in Blood Pressure

  6 months, 1 year and 3 years

• Change in Low Density Lipoprotein (LDL) cholesterol levels

  6 months, 1 year and 3 years

• Change in Hemoglobin A1c markers

  6 months, 1 year and 3 years

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

This arm involves an active intervention with health coaching and lifestyle changes.

Behavioral: Lifestyle Intervention

Standard Health Education

ACTIVE COMPARATOR

This arm receives a standard educational approach without the intensive intervention.

Other: Standard Health Education

Interventions

Lifestyle Intervention BEHAVIORAL

This arm involves interventions like health coaching, dietary changes, exercise programs, and other lifestyle modifications.

Lifestyle Intervention

Standard Health Education OTHER

Participants in the Standard of Care Arm will receive basic educational materials focused on general cognitive and physical health maintenance.

Standard Health Education

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Willingness to Participate: Participants must be willing to adhere to the study protocol, including attending assessments, participating in interventions, and completing questionnaires.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Healthy Minds Initiative: lead
• American College of Lifestyle Medicine: collaborator
• Charles Drew University of Medicine and Science: collaborator
• University of California, Los Angeles: collaborator
• Stanford University: collaborator

Study Sites (1)

Crenshaw Christian Center

Los Angeles, California, 90044, United States

RECRUITING

Related Publications (16)

• 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.

  PMID: 39096926 BACKGROUND

• Schippinger 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.

  PMID: 37097299 BACKGROUND

• Willroth 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.

  PMID: 38880341 BACKGROUND

• Dominguez 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.

  PMID: 34836334 BACKGROUND

• Ward 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.

  PMID: 34933996 BACKGROUND

• Dhana 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.

  PMID: 32554763 BACKGROUND

• Low 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.

  PMID: 36546406 BACKGROUND

• Aranda 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.

  PMID: 34245588 BACKGROUND

• Liu 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.

  PMID: 36162365 BACKGROUND

• Lennon 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.

  PMID: 34854531 BACKGROUND

• Sherzai 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.

  PMID: 26862150 BACKGROUND

• Sherzai 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.

  PMID: 31523210 BACKGROUND

• 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.

  PMID: 26086182 BACKGROUND

• Barnes 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.

  PMID: 37466280 BACKGROUND

• Morris 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.

  PMID: 25681666 BACKGROUND

• McLeod A, Bernabe BP, Xia Y, Sanchez-Flack J, Lamar M, Schiffer L, Hemphill NO, Fantuzzi G, Maki P, Fitzgibbon M, Tussing-Humphreys L. Exploring the Effects of a Mediterranean Diet and Weight Loss on the Gut Microbiome and Cognitive Performance in Older, African American Obese Adults: A Post Hoc Analysis. Nutrients. 2023 Jul 27;15(15):3332. doi: 10.3390/nu15153332.

  PMID: 37571270 BACKGROUND

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Dean Sherzai, MD, PhD

  Healthy Minds Initiative

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dean Sherzai, MD, PhD

CONTACT

949-383-6729; dean@healthymindsinitiative.org

Caroline Segalla, BA

CONTACT

808-333-2883; caroline@healthymindsinitiative.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The INSPIRE Study employs a single-blind design, where participants are unaware of their group assignment (intervention or control) to minimize bias in reporting and behavior. However, the investigators and study staff administering the interventions and conducting assessments are not blinded due to the nature of the intervention, which requires direct interaction and coaching. To further reduce potential bias, outcome assessors involved in data analysis will remain blinded to the group assignments until after the primary data analysis is completed.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 culturally relevant interventions, aiming to provide insights into the impact of lifestyle changes on cognitive health and to inform public health strategies for dementia prevention in at-risk populations.

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: December 19, 2024
• Study Start: June 1, 2025
• Primary Completion: October 13, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)