- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00911690
Establishment of a Bank of Biospecimens for Future Research on Age-related Cognitive Disorders
Establishment of a Bank of Biospecimens for the Evaluation of New Methods Facilitating Early Diagnosis and the Monitoring of Progression and Therapy of Patients With Age-related Cognitive Disorders.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Up to 1000 patients, with or without diagnosed cognitive disorders, are asked to participate by providing the investigators with blood, urine and saliva specimens to be stored in a Bio Bank for future research. Patients will be asked to participate on a yearly basis for up to 5 to 10 years by providing the investigators with the above-mentioned specimens, and also having a physical exam and having some cognitive testing performed at the initial visit and yearly visits.
Examples of the types of research are: new methods for improving the diagnosis and treatment of age-related cognitive disorders, new areas of biology, new areas of biotechnology, and possibly genetic research. If you do not want your specimens used for any specific type of research, you may specify that on the consent form.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Michigan
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Royal Oak, Michigan, États-Unis, 48073
- Beaumont Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- At least 60 years of age.
- Willing and able to complete all specimen donations and neuropsychological examinations.
- Individuals identified as having some form of cognitive impairment require a study partner with 1-2 times per week contact (can be in person and/or telephone), who will accompany them to study visits(s).
Exclusion Criteria:
- Presence of significant sensory deficits (e.g., visual or hearing), motor deficits (e.g., paralysis), or medical conditions that would preclude the completion of the neuropsychological or other study instruments.
- DMS-IV diagnosis of substance abuse disorder.
- Presence of a major medical or terminal illness that may affect the participation of the patient in the study.
- Known active malignancy, or history of malignancy within the last 5 years (other than basal cell carcinoma), severe organ failure, metabolic or hematologic disorders, or post-encephalitic syndrome.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Cognitively Impaired
Patients in this cohort with be diagnosed with mild to moderate cognitive impairment, Alzheimers disease, Dementia, or any other form of cognitive impairment.
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Non-cognitively impaired
Patients in this cohort will be normal healthy adults over the age of 60 years that have no cognitive impairment.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Tissue bank of biological specimens
Délai: 5-10 years
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To establish a tissue bank of blood, urine and saliva from cognitively normal and cognitively impaired individuals 60 years or older to be used for the purpose of conducting research addressing: etiology, mechanism, diagnosis, and treatment of age-related cognitive disorders.
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5-10 years
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Khaled Imam, M.D., Beaumont Hospitals
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2008-065
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .