Establishment of a Bank of Biospecimens for Future Research on Age-related Cognitive Disorders

Completed

• Conditions: Dementia; Alzheimers Disease

• Registration Number: NCT00911690
• Lead Sponsor: William Beaumont Hospitals

Brief Summary

This study is collecting tissue specimens (blood, urine and saliva) from up to 1000 patients, with and without cognitive disorders, to store in the Bio Bank for future research. The specimens could be used in future research projects that could help improve the accuracy of diagnosis of a disease, predict who might develop a disease, help monitor the disease, or improve the understanding of the disease. Patients are only being recruited from Beaumont Hospitals Geriatric Clinic.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-06-01
• Study First Posted: 2009-06-02
• Study Start: 2009-07
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-03
• Last Update Posted: 2016-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

1. At least 60 years of age.
2. Willing and able to complete all specimen donations and neuropsychological examinations.
3. 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

1. 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.
2. DMS-IV diagnosis of substance abuse disorder.
3. Presence of a major medical or terminal illness that may affect the participation of the patient in the study.
4. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tissue bank of biological specimens	5-10 years	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.

Trial Locations

Locations (1)

Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States