drugset / Trial / NCT02913664
Risk Reduction for Alzheimer's Disease
Phase 2/3
Completed
513 enrolled
University of Texas Southwestern Medical Center
Michigan State University · collabPennington Biomedical Research Center · collabTexas Health Resources · collabUniversity of Kansas Medical Center · collabWashington University School of Medicine · collab
RandomizedFactorialSingle-blindPrevention
Summary
Physical inactivity, high blood pressure and dyslipidemia are risk factors for Alzheimer's disease (AD) and vascular dementia. Importantly, these risk factors are modifiable with lifestyle changes, pharmacological treatment, or both. The rrAD study will determine effects of aerobic exercise training and intensive vascular risk reduction on cognitive performance in older adults who have high risk for AD.
Timeline
- Start
- 2017-02-02
- Primary completion
- 2021-11-30
- Completion
- 2022-01-31
Outcome
Missed primary endpoint
paper For the primary outcome, there were no statistically significant interactions between intervention groups and time of visits (P = .13). PMID 41870419 ↗
paper with no significant group differences (0.1 units; 95% CI, -0.1 to 0.2; P = .37). PMID 41870419 ↗
Publications
- Zhang R, Vidoni E, Vongpatanasin W, Kerwin DR, Cullum CM, Rossetti H, Stowe AM, Billinger SA, Gupta A, Hall T, Scheel N, Zhu DC, Hynan LS, Burns JM, Keller JN, Binder EF. Effects of Exercise and Intensive Vascular Risk Reduction on Cognitive Function in Older Adults: A Randomized Clinical Trial. JAMA Neurol. 2026 May 1;83(5):424-434. doi: 10.1001/jamaneurol.2026.0359.
- Szabo-Reed A, Clutton J, White S, Van Sciver A, White D, Morris J, Martin L, Lepping R, Shaw A, Puchalt JP, Montgomery R, Mahnken J, Washburn R, Burns J, Vidoni ED. COMbined Exercise Trial (COMET) to improve cognition in older adults: Rationale and methods. Contemp Clin Trials. 2022 Jul;118:106805. doi: 10.1016/j.cct.2022.106805. Epub 2022 May 27.
- Vidoni ED, Kamat A, Gahan WP, Ourso V, Woodard K, Kerwin DR, Binder EF, Burns JM, Cullum M, Hynan LS, Vongpatanasin W, Zhu DC, Zhang R, Keller JN. Baseline Prevalence of Polypharmacy in Older Hypertensive Study Subjects with Elevated Dementia Risk: Findings from the Risk Reduction for Alzheimer's Disease Study (rrAD). J Alzheimers Dis. 2020;77(1):175-182. doi: 10.3233/JAD-200122.
- Gottesman RF. To INFINITY and Beyond: What Have We Learned and What Is Still Unknown About Blood Pressure Lowering and Cognition? Circulation. 2019 Nov 12;140(20):1636-1638. doi: 10.1161/CIRCULATIONAHA.119.042827. Epub 2019 Nov 11. No abstract available.
- Szabo-Reed AN, Vidoni E, Binder EF, Burns J, Cullum CM, Gahan WP, Gupta A, Hynan LS, Kerwin DR, Rossetti H, Stowe AM, Vongpatanasin W, Zhu DC, Zhang R, Keller JN. Rationale and methods for a multicenter clinical trial assessing exercise and intensive vascular risk reduction in preventing dementia (rrAD Study). Contemp Clin Trials. 2019 Apr;79:44-54. doi: 10.1016/j.cct.2019.02.007. Epub 2019 Mar 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlodipine | Other / unclassified | — | — |
| Subject | Atorvastatin | Small molecule | 80 mg | — |
| Subject | Losartan | Other / unclassified | — | — |