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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00911690
Recruitment Status : Completed
First Posted : June 2, 2009
Last Update Posted : November 4, 2016
Information provided by (Responsible Party):
Khaled Imam, 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.

Condition or disease
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 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 : July 2009
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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.

Primary Outcome Measures :
  1. Tissue bank of biological specimens [ Time Frame: 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.

Biospecimen Retention:   Samples With DNA
Serum, Plasma, human platelet, urine (clarified), urine sediment, saliva

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00911690

United States, Michigan
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Principal Investigator: Khaled Imam, M.D. Beaumont Hospitals

Responsible Party: Khaled Imam, Director, Division of Geriatric Medicine, William Beaumont Hospitals Identifier: NCT00911690     History of Changes
Other Study ID Numbers: 2008-065
First Posted: June 2, 2009    Key Record Dates
Last Update Posted: November 4, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If IPD are shared, it will be results of genomic and proteomic testing. As this testing was done throughout the study and is ongoing, some results are already available. Anyone interested would contact the principal investigator.

Keywords provided by Khaled Imam, William Beaumont Hospitals:
Alzheimers Disease
Cognitive Disorders
Tissue Banking

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders