Alzheimer's Disease Core Center (ADCC)

This study is currently recruiting participants.

See

Contacts and Locations

Verified January 2015 by University of Arizona

Sponsor:

ClinicalTrials.gov Identifier:

NCT01421420

First Posted: August 22, 2011

Last Update Posted: June 12, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

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

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

Genetic and Rare Diseases Information Center resources: Familial Alzheimer 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

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 )
First Submitted:	July 25, 2011
First Posted:	August 22, 2011
Last Update Posted:	June 12, 2015
Last Verified:	January 2015

Keywords provided by University of Arizona:


Alzheimer's Dementia Mild Cognitive Impairment

Additional relevant MeSH terms:


Alzheimer Disease Cognitive Dysfunction Memory Disorders Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies	Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms

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