Alzheimer's DiseaseREVEAL INCT00571025
Risk Evaluation and Education for Alzheimer's Disease
A study testing APOE Disclosure in people with Alzheimer's Disease, run by National Human Genome Research Institute (NHGRI) at 3 sites in United States.
Trial summary
The purpose of this study is to determine the characteristics of those who obtain genetic susceptibility testing for Alzheimer's disease with APOE disclosure and to study the psychological and behavioral consequences of providing this information. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- APOE Disclosure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2000to Apr 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult children of a person with clinically diagnosed and/or autopsy-confirmed Alzheimer's disease
- 18 years or older
Who cannot join
- Current dementia
- Current untreated depression
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boston University School of Medicine
Boston, Massachusetts, 02118
Case Western Reserve University
Cleveland, Ohio, 44120
Weill Medical College of Cornell University
New York, New York, 10021
About this study
Official title: Genetic Risk Assessment and Counseling for Alzheimer's Disease
The purpose of this study is to determine the characteristics of those who obtain genetic susceptibility testing for Alzheimer's disease with APOE disclosure and to study the psychological and behavioral consequences of providing this information.
Read the detailed description
Advances in genetic research have led to an increased number of testing procedures to determine future risk of disease among at-risk individuals. An increasing number of genes are being identified that confer susceptibility for a given disease rather than inevitably causing it. Given that such genes may provide risk information for common diseases (e.g., stroke, depression), there is a growing need to understand how at-risk populations might respond to the option of genetic susceptibility testing. A prominent case in point is Alzheimer's disease (AD).
Participation in this study requires an initial phone call which will elicit some medical and family history information about the participant. A first in-person visit to the clinic will consist of an education session and the administration of some tests to assess memory and thinking skills. This visit will take approximately 2-3 hours. Approximately 2 weeks later, participants will return to have their blood drawn for genetic testing. Participants will then be randomized to one of two groups. Those in the experimental arm will receive information on their risk based on their family history and APOE genotype, while those in the active comparator arm will receive information on their risk for developing Alzheimer's disease based on their family history alone. Participants will be followed for 1 year following disclosure of results with 2 additional clinic visits.
- Conditions
- Alzheimer's Disease
- Being tested
- APOE Disclosure
- Keywords
- Mild Cognitive Impairment, disease/disorder proneness/risk, family genetics, genetic counseling, genetic marker, genetic polymorphism, genetic susceptibility
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Disease Susceptibility, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APOE DisclosureBehavioural
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AD risk assessment based on family history and APOE genotype Receives: Behavioral: APOE Disclosure |
| 2 | Active comparator | AD risk assessment based on family history alone Receives: Behavioral: APOE Disclosure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center for Epidemiological Studies-Depression Scale (CES-D)
Measured: baseline, 6 weeks, 6 months, 12 months post-disclosure
Beck Anxiety Inventory (BAI)
Measured: baseline, 6 weeks, 6 months, 12 months post-disclosure
Secondary outcomes (3)
Impact of Events Scale (IES)
Measured: 6 weeks, 6 months, 12 months post-disclosure
Future Attitudes Scale (FAS)
Measured: baseline, 6 weeks, 6 months, 12 months post-disclosure
Positive and Negative Affect Schedule (PANAS)
Measured: baseline, 6 weeks, 6 months, 12 months post-disclosure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startAug 2000
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institute on Aging (NIA)
- Investigators
- Robert C. Green, MD, MPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571025
- Sponsor's protocol ID
- IA0126
- Other IDs
- 5R01HG002213
- Acronym
- REVEAL I
- Status last verified
- Jul 2009
- First submitted
- 7 Dec 2007
- Last updated
- 23 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Farrer LA, Cupples LA, Haines JL, Hyman B, Kukull WA, Mayeux R, Myers RH, Pericak-Vance MA, Risch N, van Duijn CM. Effects of age, sex, and ethnicity on the association between apolipoprotein E genotype and Alzheimer disease. A meta-analysis. APOE and Alzheimer Disease Meta Analysis Consortium. JAMA. 1997 Oct 22-29;278(16):1349-56.
PubMed 9343467Green RC, Clarke VC, Thompson NJ, Woodard JL, Letz R. Early detection of Alzheimer disease: methods, markers, and misgivings. Alzheimer Dis Assoc Disord. 1997;11 Suppl 5:S1-5; discussion S37-9. doi: 10.1016/s0197-4580(96)80334-4.
PubMed 9348421Green RC, Cupples LA, Go R, Benke KS, Edeki T, Griffith PA, Williams M, Hipps Y, Graff-Radford N, Bachman D, Farrer LA; MIRAGE Study Group. Risk of dementia among white and African American relatives of patients with Alzheimer disease. JAMA. 2002 Jan 16;287(3):329-36. doi: 10.1001/jama.287.3.329.
PubMed 11790212Green RC, Roberts JS, Cupples LA, Relkin NR, Whitehouse PJ, Brown T, Eckert SL, Butson M, Sadovnick AD, Quaid KA, Chen C, Cook-Deegan R, Farrer LA; REVEAL Study Group. Disclosure of APOE genotype for risk of Alzheimer's disease. N Engl J Med. 2009 Jul 16;361(3):245-54. doi: 10.1056/NEJMoa0809578.
PubMed 19605829
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Risk Assessment and Counseling for Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00571025
- Acronym / sponsor ID
- REVEAL I / IA0126
- Conditions
- Alzheimer's Disease
- Keywords
- Mild Cognitive Impairment, disease/disorder proneness/risk, family genetics, genetic counseling, genetic marker, genetic polymorphism, genetic susceptibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Aug 2000
- Study completion
- Apr 2004 (actual)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the characteristics of those who obtain genetic susceptibility testing for Alzheimer's disease with APOE disclosure and to study the psychological and behavioral consequences of providing this information.
Detailed description
Advances in genetic research have led to an increased number of testing procedures to determine future risk of disease among at-risk individuals. An increasing number of genes are being identified that confer susceptibility for a given disease rather than inevitably causing it. Given that such genes may provide risk information for common diseases (e.g., stroke, depression), there is a growing need to understand how at-risk populations might respond to the option of genetic susceptibility testing. A prominent case in point is Alzheimer's disease (AD).
Participation in this study requires an initial phone call which will elicit some medical and family history information about the participant. A first in-person visit to the clinic will consist of an education session and the administration of some tests to assess memory and thinking skills. This visit will take approximately 2-3 hours. Approximately 2 weeks later, participants will return to have their blood drawn for genetic testing. Participants will then be randomized to one of two groups. Those in the experimental arm will receive information on their risk based on their family history and APOE genotype, while those in the active comparator arm will receive information on their risk for developing Alzheimer's disease based on their family history alone. Participants will be followed for 1 year following disclosure of results with 2 additional clinic visits.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: APOE DisclosureAD risk assessment based on family history and APOE genotype |
| 2 | Active comparator | Behavioral: APOE DisclosureAD risk assessment based on family history alone |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult children of a person with clinically diagnosed and/or autopsy-confirmed Alzheimer's disease
- 18 years or older
Key exclusion criteria (2 listed)
- Current dementia
- Current untreated depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APOE DisclosureIndividuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype. | Behavioural | 1, 2 |
Primary outcome
Center for Epidemiological Studies-Depression Scale (CES-D)
Time frame: baseline, 6 weeks, 6 months, 12 months post-disclosure
Beck Anxiety Inventory (BAI)
Time frame: baseline, 6 weeks, 6 months, 12 months post-disclosure
3 secondary outcomes
Impact of Events Scale (IES)
Time frame: 6 weeks, 6 months, 12 months post-disclosure
Future Attitudes Scale (FAS)
Time frame: baseline, 6 weeks, 6 months, 12 months post-disclosure
Positive and Negative Affect Schedule (PANAS)
Time frame: baseline, 6 weeks, 6 months, 12 months post-disclosure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2009.
- Background: PubMed 9343467Farrer LA, Cupples LA, Haines JL, Hyman B, Kukull WA, Mayeux R, Myers RH, Pericak-Vance MA, Risch N, van Duijn CM. Effects of age, sex, and ethnicity on the association between apolipoprotein E genotype and Alzheimer disease. A meta-analysis. APOE and Alzheimer Disease Meta Analysis Consortium. JAMA. 1997 Oct 22-29;278(16):1349-56.
- Background: PubMed 9348421Green RC, Clarke VC, Thompson NJ, Woodard JL, Letz R. Early detection of Alzheimer disease: methods, markers, and misgivings. Alzheimer Dis Assoc Disord. 1997;11 Suppl 5:S1-5; discussion S37-9. doi: 10.1016/s0197-4580(96)80334-4.
- Background: PubMed 11790212Green RC, Cupples LA, Go R, Benke KS, Edeki T, Griffith PA, Williams M, Hipps Y, Graff-Radford N, Bachman D, Farrer LA; MIRAGE Study Group. Risk of dementia among white and African American relatives of patients with Alzheimer disease. JAMA. 2002 Jan 16;287(3):329-36. doi: 10.1001/jama.287.3.329.
- Derived from this study: PubMed 19605829Green RC, Roberts JS, Cupples LA, Relkin NR, Whitehouse PJ, Brown T, Eckert SL, Butson M, Sadovnick AD, Quaid KA, Chen C, Cook-Deegan R, Farrer LA; REVEAL Study Group. Disclosure of APOE genotype for risk of Alzheimer's disease. N Engl J Med. 2009 Jul 16;361(3):245-54. doi: 10.1056/NEJMoa0809578.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert C. Green, MD, MPH principal investigator
Boston University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APOE Disclosure in people with Alzheimer's Disease, run by National Human Genome Research Institute (NHGRI) at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Center for Epidemiological Studies-Depression Scale (CES-D) (time frame: baseline, 6 weeks, 6 months, 12 months post-disclosure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00571025, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2009.