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Alzheimer's Disease Core Center (ADCC)
This study is currently recruiting participants.
Verified January 2015 by University of Arizona
Sponsor:
University of Arizona
Collaborators:
Banner Health
Barrow Neurological Foundation
Mayo Clinic
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01421420
First received: July 25, 2011
Last updated: June 10, 2015
Last verified: January 2015
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Purpose
The main objective of this research project is to provide a comprehensive clinical database of patients with Alzheimer's disease (AD) and other forms of dementia, individuals with mild cognitive impairment (MCI), and age-matched normal controls. The study will also attempt to identify cognitively normal individuals at genetically defined risk for Alzheimer's disease through genetic screening.
All participants are seen annually. Autopsies to establish diagnoses in patients with dementia, patients with mild MCI, and cognitively normal elderly control subjects will also be conducted.
| Condition |
|---|
| Alzheimer's Disease Mild Cognitive Impairment Age-Related Memory Disorders |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Arizona Alzheimer's Disease Core Center |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by University of Arizona:
Primary Outcome Measures:
- Neuropsychological Test Scores [ Time Frame: Up to 20 years ]Cognitive function will be evaluated on a yearly basis using a battery of neuropsychological tests, which will then be scored and normed according to established guidelines.
Secondary Outcome Measures:
- Neurological Exam [ Time Frame: Up to 20 Years ]A thorough neurological exam will be performed once per year to evaluate neurological function.
- Brain Tissue [ Time Frame: From date of entry until date of death assessed up to 20 years ]A brain autopsy will be performed upon the participant's death to establish histological diagnosis.
Biospecimen Retention: Samples With DNA
blood, saliva, brain tissue
| Estimated Enrollment: | 900 |
| Study Start Date: | July 2001 |
| Estimated Study Completion Date: | July 2025 |
| Estimated Primary Completion Date: | December 2024 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Alzheimer's Disease |
| Mild Cognitive Impairment |
| Other forms of Dementia, not AD |
| Normal Elderly Individuals |
Detailed Description:
All participants are seen annually. In addition to a detailed neurological examination, participants will receive a standardized battery of neuropsychological tests and will undergo genetic testing. The investigators will provide standardized periodic longitudinal assessment of the research participants. Autopsies to establish neurohistopathological diagnoses in clinically well-characterized patients with dementia, patients with mild MCI, and cognitively normal elderly control subjects will also be conducted.
Eligibility| Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Individuals with Alzheimer's disease, mild cognitive impairment, other forms of dementia, and normal elderly individuals.
Criteria
Inclusion Criteria:
For patients with MCI, or dementia, the presence of cognitive deficits including memory, language, and executive function.
Exclusion Criteria:
Presence of non-neurological medical conditions interfering with cognition.
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: NCT01421420
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421420
Locations
| United States, Arizona | |
| University of Arizona, University Medical Center | Recruiting |
| Tucson, Arizona, United States, 85724 | |
| Contact: Kim Corley, B.A. 520-626-3746 kgcorley@email.arizona.edu | |
| Principal Investigator: Steven Z Rapcsak, M.D. | |
Sponsors and Collaborators
University of Arizona
Banner Health
Barrow Neurological Foundation
Mayo Clinic
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Investigators
| Principal Investigator: | Steven Z Rapcsak, M.D. | University of Arizona |
More Information
| Responsible Party: | University of Arizona |
| ClinicalTrials.gov Identifier: | NCT01421420 History of Changes |
| Other Study ID Numbers: |
P30AG019610 ( U.S. NIH Grant/Contract ) |
| Study First Received: | July 25, 2011 |
| Last Updated: | June 10, 2015 |
Keywords provided by University of Arizona:
|
Alzheimer's Dementia Mild Cognitive Impairment |
Additional relevant MeSH terms:
|
Alzheimer Disease Cognition Disorders Mild Cognitive Impairment Memory Disorders Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on August 21, 2017