Table 2.
Characteristics of the research subjects and randomization in the four Risk Evaluation and Education for Alzheimer’s Disease (REVEAL) Study trials
| Subjects | Randomized study armsa | ||
|---|---|---|---|
| Comparison | Intervention | ||
| REVEAL I (2000--2003) |
Cognitively normal adults with a first-degree relative with AD |
Genotype nondisclosure (AD risk excluding APOE) |
Genotype disclosure (AD risk including APOE) |
| REVEAL II (2003--2006) |
Same as REVEAL I, but including older adults and targeted recruitment of African Americans |
Standard protocol (in-person educational session, extended counseling); Genotype disclosure (AD risk including APOE) |
Condensed protocol (mailed educational brochure, abbreviated counseling); Genotype disclosure (AD risk including APOE) |
| REVEAL III (2006--2009) |
Cognitively normal adults with or without a family history of AD |
Condensed protocol; Genotype disclosure (AD risk including APOE) |
Condensed protocol; Genotype disclosure (AD risk including APOE, plus APOE-associated risk of cardiovascular disease) |
| In-person risk disclosure | Telephone risk disclosure | ||
| REVEAL IV (2010--2013) |
Persons with a diagnosis of mild cognitive impairment |
Standard protocol; Genotype nondisclosure (AD risk excluding APOE) |
Standard protocol; Genotype disclosure (AD risk including APOE) |
a
In REVEAL I, II, and IV, subjects were 1:2 randomized for the comparison:intervention assignment. In REVEAL III, subjects were double randomized (factorial design) to receive either Alzheimer’s disease (AD) risk information alone or AD risk plus APOE-associated cardiovascular risk information and to receive either in-person risk disclosure or telephone risk disclosure.