Alzheimer's Disease Core Center (ADCC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Arizona
Sponsor:
Collaborators:
Banner Sun Health Research Institute
Barrow Neurological Foundation
Mayo Clinic
Information provided by (Responsible Party):
University of Arizona
ClinicalTrials.gov Identifier:
NCT01421420
First received: July 25, 2011
Last updated: May 19, 2014
Last verified: May 2014
  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:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Neuropsychological Test Scores [ Time Frame: Up to 20 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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

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 Sun Health Research Institute
Barrow Neurological Foundation
Mayo Clinic
Investigators
Principal Investigator: Steven Z Rapcsak, M.D. University of Arizona
  More Information

No publications provided

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT01421420     History of Changes
Other Study ID Numbers: P30AG19610, P30AG019610
Study First Received: July 25, 2011
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Arizona:
Alzheimer's
Dementia
Mild Cognitive Impairment

Additional relevant MeSH terms:
Alzheimer Disease
Memory Disorders
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on August 26, 2014