N/A
Completed N=172
Systematic Multi-domain Alzheimer's Risk Reduction Trial
Source: ClinicalTrials.gov NCT03683394 ↗Enrolled (actual)
172
Serious AEs
27.3%
Results posted
Sep 2023
Primary outcomePrimary: Cognitive Change — 0.34; 0.19 z-score — p=0.008
Summary
The primary goal of this randomized controlled trial (RCT) is to pilot-test a personalized, pragmatic, multi-domain Alzheimer's disease risk reduction intervention in a U.S. integrated healthcare delivery system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Change |
0.34; 0.19 | 0.008 sig |
| SECONDARY Change in Targeted Risk Factors |
0.06; -0.05 | 0.002 sig |
| SECONDARY Quality of Life Measure |
12.69; 11.58 | 0.03 sig |
| SECONDARY Number of Participants With Mild Cognitive Impairment, Alzheimer's Disease, and Dementia |
5; 8 | 0.52 |
Eligibility Criteria
Inclusion Criteria
- 70-89 Years of Age
- Fluent in the English Language
- Low-normal performance on a brief telephone cognitive screen, measured using the Cognitive Abilities Screening Instruments (CASI). Low-normal scores are defined as 26-29.
- Has at least two additional risk factors that will be targeted by the intervention.
Exclusion Criteria
- Residing in a skilled nursing or rehabilitation facility
- Receiving palliative care or hospice services
- Charlson comorbidity index score of greater than 5
- Bipolar illness or schizophrenia
- Current alcohol or drug use disorder
- Receiving chronic opioid therapy
- Parkinson's disease, amyotrophic lateral sclerosis, or multiple sclerosis
- Severe visual or hearing impairment
- Requests not to be contacted or not to have their medical record reviewed for research
- Prior evidence of dementia
Data sourced from ClinicalTrials.gov (NCT03683394). 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. Informational only — not medical advice.