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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Khaled Imam, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00911690
First received: May 29, 2009
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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
Dementia
Alzheimers Disease

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Tissue bank of biological specimens [ Time Frame: 5-10 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1000
Study Start Date: July 2009
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911690

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

No publications provided

Responsible Party: Khaled Imam, Director, Division of Geriatric Medicine, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00911690     History of Changes
Other Study ID Numbers: 2008-065
Study First Received: May 29, 2009
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Dementia
Alzheimers Disease
Cognitive Disorders
Tissue Banking

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014