Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462917
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2007-04-17
Brief Title:
REVEAL III Risk Evaluation and Education for Alzheimers Disease
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Risk Evaluation and Education for Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVEAL
Brief Summary:
The purpose of this study is to provide healthy adults with genetic testing and information about their chances of developing Alzheimers disease
Detailed Description:
Alzheimers 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 that has been identified which can provide information about a persons chances of developing Alzheimers diseases Previous research explored the behavioral and psychological impact of receiving genetic risk information for Alzheimers disease AD The REVEAL I Study funded in 1999 showed that an Alzheimers disease genetic risk assessment can be given to relatives of people with AD in a safe way REVEAL II which was funded in 2003 demonstrated that this same information can be given in a condensed education and counseling protocol without causing severe psychological harm REVEAL III will further study different ways of providing genetic risk information for Alzheimers disease
Participation in this study will entail an initial screening phone call to determine eligibility followed by a phone interview which will ask about demographic information and thoughts and feelings about AD Participants will complete a mailed survey Following completion of the survey a genetic counselor will meet with the participant at the clinic to review family and medical history administer additional questionnaires asking about AD and genetic testing and draw blood for genetic testing Results will be disclosed either in person or over the phone about 3 to 4 weeks later The genetic counselor will make a brief follow-up phone call 1 week after that The participant will visit the clinic twice to provide additional information at 6 weeks and 6 months after disclosure Finally the participant will complete a mailed 12 month survey and the genetic counselor will make a brief follow-up phone call
Participation in this study will entail an initial screening phone call to determine eligibility followed by a phone interview which will ask about demographic information and thoughts and feelings about AD Participants will complete a mailed survey Following completion of the survey a genetic counselor will meet with the participant at the clinic to review family and medical history administer additional questionnaires asking about AD and genetic testing and draw blood for genetic testing Results will be disclosed either in person or over the phone about 3 to 4 weeks later The genetic counselor will make a brief follow-up phone call 1 week after that The participant will visit the clinic twice to provide additional information at 6 weeks and 6 months after disclosure Finally the participant will complete a mailed 12 month survey and the genetic counselor will make a brief follow-up phone call
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HG002213 | NIH | None | httpsreporternihgovquickSearchR01HG002213 |