Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00089882
Status:
COMPLETED
Last Update Posted:
2009-07-23
First Post:
2004-08-17
Brief Title:
Risk Evaluation and Education for Alzheimers Disease REVEAL II
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
Risk Evaluation and Education for Alzheimers Disease REVEAL II
Status:
COMPLETED
Status Verified Date:
2009-07
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:
None
Brief Summary:
The REVEAL II study provides healthy adult children and siblings of Alzheimers disease patients with genetic testing and information about their own chances of developing the disease The study will compare a condensed education and counseling program to the current more extensive program
Detailed Description:
Alzheimers disease AD is a common progressive disease affecting memory and cognition Apolipoprotein E APOE has been identified as a genetic factor that may increase the risk of developing Alzheimers disease AD While several consensus statements have advised against the clinical use of APOE genotyping each of these called for research to evaluate the impact of susceptibility genotyping and to explore the process of communicating about risk issues The REVEAL I Study was funded in 1999 to enroll adult children of patients with AD to determine who would choose to obtain APOE genotyping to devise an education and counseling protocol for the disclosure of APOE genotyping and to study the impact of disclosing this information The REVEAL I study demonstrated that Alzheimers disease risk assessments with APOE genotyping can be given to relatives of people with Alzheimers disease without causing severe adverse psychological or behavioral effects
The REVEAL II study will examine whether receiving risk assessment and APOE genotyping disclosure through a Condensed Education and Counseling Protocol is as safe and as effective as receiving such information through our current Extended Protocol This study will also examine whether there are any differences among groups who receive disclosure of APOE results and risk assessment by different provider types such as a physician or a genetic counselor At least one-third of the participants in REVEAL II will be African American in order to explore how racial identity affects the desire to obtain genetic risk assessment and the impact of receiving it
Individuals who have a parent or sibling affected by Alzheimers disease may enter the study either by self-referral to the study coordinator or by recruitment Participants will have a scheduled phone interview during which demographic information their relatives medical history attitudes toward genetic testing and risk assessment for Alzheimers disease and interest in going on to the next step of the study will be assessed During the second step of the study participants will be randomly assigned to one of three study arms Participants in the control arm of the study will be given the full educational and counseling protocol as was originally developed in the first funding period of this study All participants will have the opportunity to continue with the study and have their blood drawn for genotype analysis and risk assessment Follow-up sessions will be provided with psychometric measures and questionnaires
Participants will be seen by the genetic counselor for two follow-up appointments six weeks and six months after disclosure of risk information A final 12 month follow-up questionnaire will be completed by mail and will be followed by a phone call from the genetic counselor
The REVEAL II study will examine whether receiving risk assessment and APOE genotyping disclosure through a Condensed Education and Counseling Protocol is as safe and as effective as receiving such information through our current Extended Protocol This study will also examine whether there are any differences among groups who receive disclosure of APOE results and risk assessment by different provider types such as a physician or a genetic counselor At least one-third of the participants in REVEAL II will be African American in order to explore how racial identity affects the desire to obtain genetic risk assessment and the impact of receiving it
Individuals who have a parent or sibling affected by Alzheimers disease may enter the study either by self-referral to the study coordinator or by recruitment Participants will have a scheduled phone interview during which demographic information their relatives medical history attitudes toward genetic testing and risk assessment for Alzheimers disease and interest in going on to the next step of the study will be assessed During the second step of the study participants will be randomly assigned to one of three study arms Participants in the control arm of the study will be given the full educational and counseling protocol as was originally developed in the first funding period of this study All participants will have the opportunity to continue with the study and have their blood drawn for genotype analysis and risk assessment Follow-up sessions will be provided with psychometric measures and questionnaires
Participants will be seen by the genetic counselor for two follow-up appointments six weeks and six months after disclosure of risk information A final 12 month follow-up questionnaire will be completed by mail and will be followed by a phone call from the genetic counselor
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 |
|---|---|---|---|
| Boston University SOM H-23380 | US NIH GrantContract | None | httpsreporternihgovquickSearch2R01HG002213-04 |
| 2R01HG002213-04 | NIH | None | None |