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

24 septembre 2018 mis à jour par: 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).

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

146

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • États-Unis
    • District of Columbia
      • Washington, District of Columbia, États-Unis, 20060
        • Howard University
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48109
        • University of Michigan
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • University of Pennsylvania

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: APOE Genotype Non-Disclosure
Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.
Comportemental: 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.
Expérimental: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Geriatric Depression Scale
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Impact of Event Scale (IES)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Brigham and Women's Hospital

Collaborateurs

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

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2010

Achèvement primaire (Réel)

1 juillet 2014

Achèvement de l'étude (Réel)

1 juillet 2014

Dates d'inscription aux études

Première soumission

7 septembre 2011

Première soumission répondant aux critères de contrôle qualité

14 septembre 2011

Première publication (Estimation)

15 septembre 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 octobre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 septembre 2018

Dernière vérification

1 septembre 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • R01HG002213 (Subvention/contrat des NIH des États-Unis)

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