N/A
N=38
Brain Connections and Blood Pressure
Hypertension · Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03736434 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Change in Resting State Network
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mindfulness and DASH Diet Education (Behavioral); Education group (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Resting State Network |
— | — |
| PRIMARY Change in Systolic Blood Pressure |
-10.4; -3.2; -13.8 | — |
| PRIMARY Change in Diastolic Blood Pressure |
-4.1; -3.4; -5.7 | — |
| SECONDARY Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q) Change |
-1.6; 0.2; -6 | — |
| SECONDARY Cognitive and Affective Mindfulness Scale Change |
-3.1; -2.1; 3.9 | — |
| SECONDARY Perceived Stress Scale Change |
1.2; 0.8; -5.9 | — |
Summary
This pilot randomized controlled study evaluates Mindfulness and DASH Diet resting state network and blood pressure in 36 (n=12 intervention; n=12 attention control; n = 12 control) Black and African American older adults with early Alzheimer's disease and related dementia disorders and hypertension.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of hypertension with or without medication use
- Diagnosis of Alzheimer's disease or related dementia disorder or, if no formal diagnosis of Alzheimer's disease, then a Self-Assessment Gerocognitive Evaluation score 17-10 or a Montreal Cognitive Assessment Screen 25-19
Exclusion Criteria
- Unable to understand spoken English
- Expect to move out of the area within six months
- fMRI imaging contraindicated (history of shrapnel, metal in the body, heart pacemaker, heart defibrillator, metal in the eye, gunshot wound, or some types of metal elsewhere within the body such as certain surgical clips for aneurysms in the head, heart valve prostheses, electrodes, and some other implanted devices) or claustrophobia. However, the participant can be included in the study without fMRI.
- Self-reported history of a stroke
- <6 on the Brief Assessment of Understanding of the Study
Data sourced from ClinicalTrials.gov (NCT03736434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.