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

NCT00911690 | Completed

• 1 other identifier: 2008-065
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Alzheimers Disease

Keywords

Dementia; Alzheimers Disease; Cognitive Disorders; Tissue Banking

Outcome Measures

Primary Outcomes (1)

• Tissue bank of biological specimens

  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.

  5-10 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be obtained from individuals seen by the physicians affiliated with the Division of Geriatric Medicine at Beaumont Hospital in the Geriatric Clinic.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Plasma, human platelet, urine (clarified), urine sediment, saliva

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cognition Disorders

Study Officials

• Khaled Imam, M.D.

  Beaumont Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Geriatric Medicine

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 2, 2009
• Study Start: July 1, 2009
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 4, 2016

Record last verified: 2016-11

Locations

US (1)