Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV



Status:Completed
Conditions:Alzheimer Disease, Cognitive Studies
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:10/25/2018
Start Date:January 2010
End Date:July 2014

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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).

Alzheimer's disease is a common condition affecting memory and thinking. Genes can sometimes
be used to provide risk estimates for the eventual development of certain common diseases.
Apolipoprotein E (APOE) is one gene which can provide information about a person's chances of
developing Alzheimer's disease.

Some people with a diagnosis of Mild Cognitive Impairment (MCI) are curious to learn more
about the chance of developing Alzheimer's disease. In the REVEAL IV Study, we are examining
the psychological and behavioral impact of learning genetic risk information pertaining to
the chance for an individual with MCI to progress to dementia of the Alzheimer's type within
three years.

Participation in this study requires an initial phone call which will elicit some demographic
information about the participant and his or her study partner. A first in-person visit to
the research clinic will consist of an education session, the administration of knowledge and
attitudinal surveys and some tests to assess memory and thinking skills. This visit will take
approximately 2-3 hours. Participants with MCI will have their blood drawn for genetic
testing. Participants will then be randomized to one of two groups. Those in the intervention
arm will receive a three-year risk estimate for the chance of progressing to dementia of the
Alzheimer's type based on age, the diagnosis of MCI and their own APOE gene test result.
Those in the comparison arm will receive a three-year risk estimate for the chance of
progressing to dementia of the Alzheimer's type based on age and the diagnosis of MCI,
without the APOE gene test result. Participants randomized to the comparison arm will have
the opportunity to learn their own APOE gene test result at the end of the study.
Participants and their study partners will be followed for 6 months following disclosure of
results with 1 additional clinic visit and 1 additional phone interviews.

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
We found this trial at
3
sites
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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Washington, District of Columbia 20060
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Washington,
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