N/A
N=114
Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT01434667 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Geriatric Depression Scale — 2.6; 2.1; 2.8; 1.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- APOE genotype and Alzheimer's disease risk disclosure (Behavioral); Alzheimer's disease risk disclosure (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geriatric Depression Scale |
2.6; 2.1; 2.8; 1.9; 2.1; 2.0 | — |
| PRIMARY Mini State Trait Anxiety Inventory |
36.3; 36.5; 39.0; 36.6; 36.2; 36.2 | — |
| SECONDARY Impact of Event Scale (IES) |
8.2; 8.1; 13.1; 11.5; 12.5; 12.4 | — |
| SECONDARY Psychological Impact of Test Disclosure (IGT-AD) |
24.7; 19.5; 24.1; 20.3 | — |
| SECONDARY Recall and Comprehension of Risk Information |
0.8; 1.2; 1.0; 1.2 | — |
| SECONDARY Participant Satisfaction |
6.0; 6.1; 5.9; 6.2; 5.5; 6.0 | — |
| SECONDARY User Ratings of Risk Assessment Experience |
3.5; 3.6; 3.0; 3.5 | — |
| SECONDARY Health Behavior and Insurance Changes |
6; 17; 16; 26; 7; 15 | — |
| SECONDARY Insurance and Advance Planning Changes |
2; 1; 0; 1; 0; 0 | — |
| SECONDARY Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate. |
0; 6; 2; 10 | — |
Summary
This study is intended to examine the impact of receiving a genetic risk assessment for Alzheimer's disease (AD) among individuals with Mild Cognitive Impairment (MCI).
Eligibility Criteria
Inclusion Criteria
- Individuals (55-90 years old) with Mild Cognitive Impairment (amnestic-MCI as defined by the Petersen criteria)
- Individuals who have a close friend, relative or spouse (18+) willing to be a study partner. Study partners attend each study visit with the participant and also complete surveys and interviews.
Exclusion Criteria
- Individuals with current, untreated anxiety or depression
- Individuals who do not meet the criteria for amnestic-MCI
- Individuals who have the diagnosis of dementia or Alzheimer's disease
- Individuals not fluent in English
- Individuals who do not have a study partner
Data sourced from ClinicalTrials.gov (NCT01434667). 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.