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

Sponsor

William Beaumont Hospitals (Other)

Overall Status

Completed

CT.gov ID

NCT00911690

Collaborator

(none)

102

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia Alzheimers Disease

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 Design

Study Type:

Observational

Actual Enrollment :

102 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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.

Study Start Date :

Jul 1, 2009

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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.
Non-cognitively impaired Patients in this cohort will be normal healthy adults over the age of 60 years that have no cognitive impairment.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.