- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00571025
Risk Evaluation and Education for Alzheimer's Disease (REVEAL I)
Genetic Risk Assessment and Counseling for Alzheimer's Disease
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02118
- Boston University School of Medicine
-
-
New York
-
New York, New York, Förenta staterna, 10021
- Weill Medical College of Cornell University
-
-
Ohio
-
Cleveland, Ohio, Förenta staterna, 44120
- Case Western Reserve University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Adult children of a person with clinically diagnosed and/or autopsy-confirmed Alzheimer's disease
- 18 years or older
Exclusion Criteria:
- Current dementia
- Current untreated depression
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 1
AD risk assessment based on family history and APOE genotype
|
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
|
Aktiv komparator: 2
AD risk assessment based on family history alone
|
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Center for Epidemiological Studies-Depression Scale (CES-D)
Tidsram: baseline, 6 weeks, 6 months, 12 months post-disclosure
|
baseline, 6 weeks, 6 months, 12 months post-disclosure
|
Beck Anxiety Inventory (BAI)
Tidsram: baseline, 6 weeks, 6 months, 12 months post-disclosure
|
baseline, 6 weeks, 6 months, 12 months post-disclosure
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Impact of Events Scale (IES)
Tidsram: 6 weeks, 6 months, 12 months post-disclosure
|
6 weeks, 6 months, 12 months post-disclosure
|
Future Attitudes Scale (FAS)
Tidsram: baseline, 6 weeks, 6 months, 12 months post-disclosure
|
baseline, 6 weeks, 6 months, 12 months post-disclosure
|
Positive and Negative Affect Schedule (PANAS)
Tidsram: baseline, 6 weeks, 6 months, 12 months post-disclosure
|
baseline, 6 weeks, 6 months, 12 months post-disclosure
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Robert C. Green, MD, MPH, Boston University
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- Green 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.
- Green 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.
- Green 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IA0126
- 5R01HG002213 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på APOE Disclosure
-
IUVO S.r.l.Scuola Superiore Sant'Anna di Pisa; Össur EhfRekrytering
-
Aposcience AGFGK Clinical Research GmbHAvslutadDiabetiskt fotsår (DFU)Österrike, Tjeckien, Tyskland, Polen
-
Far East Bio-Tec Co., LtdOkänd
-
Ionis Pharmaceuticals, Inc.AvslutadFörhöjt lipoprotein(a)Nederländerna, Storbritannien, Danmark, Tyskland, Kanada
-
José Mordoh, M.D., Ph.D.Avslutad
-
Centre Hospitalier Universitaire de NīmesIndragenAlzheimers sjukdom | Amyloid Cerebral AngiopatiFrankrike
-
Akcea TherapeuticsIonis Pharmaceuticals, Inc.AvslutadKardiovaskulär sjukdom | Förhöjt lipoprotein(a)Förenta staterna, Kanada, Danmark, Tyskland, Nederländerna
-
Shanghai Gebaide Biotechnology Co., Ltd.OkändIcke-småcellig lungcancer (NSCLC) Steg IVKina
-
Ionis Pharmaceuticals, Inc.Avslutad
-
Ionis Pharmaceuticals, Inc.Akcea TherapeuticsAvslutad