Clinical trial · Interventional
The Brain Health Champion Study
The Brain Health Champion Study: Promoting Non-pharmacological Interventions in Cognitive Disorders and Those at Risk
NCT03772977CI-TRIAL-00117595BHCactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
6-month, randomized, controlled investigation measuring the effect of increased clinical contact and personalization compared to standard physician counseling on adherence to consensus-based, brain health recommendations for patients with subjective cognitive decline, mild cognitive impairment, and early dementia or patients who are at risk for developing these conditions.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| At Risk for Cognitive Decline | — | UNRESOLVED | — |
| Dementia, Mild | — | UNRESOLVED | — |
| Mild Cognitive Impairment | — | UNRESOLVED | — |
| Subjective Cognitive Decline | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brain Health Champion | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Brain Health Champion (BHC)
- description
- A "health coach" intervention with weekly phone calls
- interventionNames
- Behavioral: Brain Health Champion
- type
- NO_INTERVENTION
- label
- Standard of Care (SOC)
- description
- The current physician/provider counseling on brain health to reduce cognitive decline or incidence of cognitive impairment that occurs, per providers' own practice
Primary outcomes (3)
- measure
- Self-report adherence to Mediterranean diet
- timeFrame
- 6 months
- description
- Goulet Mediterranean Diet Score (questionnaire). Measured adherence to the Mediterranean Diet. Likert Scale 0-44, with higher values indicating stronger adherence to the dietary pattern.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion criteria: * Be age 60 to 79 * Existing patient at Brigham Health system with at least one prior visit with providers and plans to establish/continue longitudinal care * Be sufficiently fluent in the English language to understand instructions and perform the cognitive and functional tests * For neurology participants only: Have a diagnosis of Subjective Cognitive Disorder (SCD) (MMSE guideline 27-30), Mild Cognitive Impairment (MCI) due to Alzheimer disease (AD), cerebrovascular disease (CVD), or mixed-type AD/CVD (MMSE guideline 24-30), or mild dementia due to AD, CVD, or mixed-AD/CVD (MMSE guideline 20-30). In some cases, based on the clinical judgment of the treating neurologist, we may enroll a patient who falls outside of these guidelines or whose diagnosis and overall level of functioning does not perfectly correlate to their MMSE score. * For primary care participants only: Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) dementia risk score of ≥ 6, or score of 5 plus one of the following: a history of ADRD in a first-degree relative, or type II diabetes or "pre-diabetes" spectrum (A1C level ≥ 5.7) Exclusion criteria: * Be enrolled in another health behavior or non-pharmacologic intervention for a neurocognitive disorder * Be unable to or unwilling to carry out regular physical exercise, multiple times weekly. * Be not recommended to participate by their Internist/Primary Care Provider due to health-related concerns.
References
Publications (1)
- BACKGROUNDSchwartz HEM, Bay CP, McFeeley BM, Krivanek TJ, Daffner KR, Gale SA. The Brain Health Champion study: Health coaching changes behaviors in patients with cognitive impairment. Alzheimers Dement (N Y). 2019 Nov 12;5:771-779. doi: 10.1016/j.trci.2019.09.008. eCollection 2019. PMID 31763431