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Alzheimer's Disease Core Center (ADCC)

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ClinicalTrials.gov Identifier: NCT01421420
Recruitment Status : Recruiting
First Posted : August 22, 2011
Last Update Posted : June 12, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Alzheimer's Disease Mild Cognitive Impairment Age-Related Memory Disorders

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.

Study Design

Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Arizona Alzheimer's Disease Core Center
Study Start Date : July 2001
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : July 2025

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Alzheimer's Disease
Mild Cognitive Impairment
Other forms of Dementia, not AD
Normal Elderly Individuals

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. Neurological Exam [ Time Frame: Up to 20 Years ]
    A thorough neurological exam will be performed once per year to evaluate neurological function.

  2. 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

Eligibility Criteria

Information from the National Library of Medicine

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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.

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

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 ClinicalTrials.gov identifier (NCT number): NCT01421420

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)
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 )
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: June 12, 2015
Last Verified: January 2015

Keywords provided by University of Arizona:
Mild Cognitive Impairment

Additional relevant MeSH terms:
Memory Disorders
Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms