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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Khaled Imam, M.D., Beaumont Hospitals

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 29, 2009
• First Submitted That Met QC Criteria: June 1, 2009
• First Posted (Estimate): June 2, 2009

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Dementia; Cognitive Disorders; Alzheimers Disease; Tissue Banking
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease; Cognition Disorders
• Other Study ID Numbers: 2008-065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD 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.