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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

May 29, 2009
July 9, 2013
July 2009
July 2015   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00911690 on ClinicalTrials.gov Archive Site
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Establishment of a Bank of Biospecimens for Future Research on Age-related Cognitive Disorders
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.

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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

Non-Probability Sample

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

  • Dementia
  • Alzheimers Disease
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1000
April 2016
July 2015   (final data collection date for primary outcome measure)

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.
Both
60 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00911690
2008-065
No
Khaled Imam, William Beaumont Hospitals
William Beaumont Hospitals
Not Provided
Principal Investigator: Khaled Imam, M.D. Beaumont Hospitals
William Beaumont Hospitals
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP