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

24. September 2018 aktualisiert von: Robert C. Green, MD, MPH, Brigham and Women's Hospital
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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

146

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • District of Columbia
      • Washington, District of Columbia, Vereinigte Staaten, 20060
        • Howard University
    • Michigan
      • Ann Arbor, Michigan, Vereinigte Staaten, 48109
        • University of Michigan
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • University of Pennsylvania

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: APOE Genotype Non-Disclosure
Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.
Verhalten: Alzheimer's disease risk disclosure
Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
Experimental: APOE Genotype Disclosure
Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.
Verhalten: APOE genotype and Alzheimer's disease risk disclosure
Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Geriatric Depression Scale
Zeitfenster: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
A 15-item self-report assessment used to identify depression in the elderly. GDS scores ranged from 0-15. Higher scores indicated greater depression.
Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
Mini State Trait Anxiety Inventory
Zeitfenster: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
Validated introspective psychological inventory consisting of 6 self-report items pertaining to anxiety affect. Responses are transformed into scores that range from 20 to 80, with higher scores indicating greater anxiety.
Baseline, 6 weeks post-disclosure, and 6 months post-disclosure

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Impact of Event Scale (IES)
Zeitfenster: 1-3 Days, 6 Weeks and 6 Months Post-disclosure
The Impact of Event assesses intrusive thoughts and avoidance related to a specific stressful life event. It is a 15-item self-report measure with scores that range from 0 to 75, with greater scores indicating greater distress about the event.
1-3 Days, 6 Weeks and 6 Months Post-disclosure
Psychological Impact of Test Disclosure (IGT-AD)
Zeitfenster: 6 Weeks and 6 Months Post-disclosure
A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress. Higher scores indicate greater distress about the risk assessment.
6 Weeks and 6 Months Post-disclosure
Recall and Comprehension of Risk Information
Zeitfenster: 6 Weeks and 6 Months Post-disclosure
Several measures to assess participant recall and comprehension of personalized risk information for AD. The sum number correct of the two items that were presented to both randomization arms ("What form of APOE increases risk for Alzheimer's disease?", and "What percentage were you given as your 3-year risk of developing Alzheimer's disease?") are summarized here.
6 Weeks and 6 Months Post-disclosure
Participant Satisfaction
Zeitfenster: 6 Weeks and 6 Months Post-disclosure
How well participants' expectations about information, explanations, reassurance, advice, and help in decision making were met. Participants rated satisfaction for each dimension on a 1-7 scale, with higher scores indicating that expectations were met better.
6 Weeks and 6 Months Post-disclosure
User Ratings of Risk Assessment Experience
Zeitfenster: 6 Weeks and 6 Months Post-disclosure
Subjective ratings of the impact of risk assessment. Participants provided ratings on a 1-5 scale, with 1 being "very negative" and 5 being "very positive"
6 Weeks and 6 Months Post-disclosure
Health Behavior and Insurance Changes
Zeitfenster: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
AD prevention behaviors enacted within the prior two weeks.
Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
Insurance and Advance Planning Changes
Zeitfenster: 6 months post-disclosure
A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning.
6 months post-disclosure
Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate.
Zeitfenster: 6 weeks and 6 months post-disclosure
Yes/no response to the question, "Since receiving your Alzheimer's disease risk estimate, have you joined any other Alzheimer's disease-related research studies?"
6 weeks and 6 months post-disclosure

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Brigham and Women's Hospital

Mitarbeiter

University of Pennsylvania
University of Michigan
National Human Genome Research Institute (NHGRI)
Howard University

Ermittler

  • Hauptermittler: Robert C Green, MD, MPH, Brigham and Women's Hospital/Harvard Medical School

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Januar 2010

Primärer Abschluss (Tatsächlich)

1. Juli 2014

Studienabschluss (Tatsächlich)

1. Juli 2014

Studienanmeldedaten

Zuerst eingereicht

7. September 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. September 2011

Zuerst gepostet (Schätzen)

15. September 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. Oktober 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

24. September 2018

Zuletzt verifiziert

1. September 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • R01HG002213 (US NIH Stipendium/Vertrag)

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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