Alzheimer's Disease Core Center

Recruiting

• Conditions: Alzheimer's Disease; Mild Cognitive Impairment; Age-Related Memory Disorders

• Registration Number: NCT01421420
• Lead Sponsor: University of Arizona

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.

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 Timeline

• Study Start: 2001-07
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-08-19
• Study First Posted: 2011-08-22
• Status Verified: 2015-01
• Last Update Submitted: 2015-06-10
• Last Update Posted: 2015-06-12
• Primary Completion: 2024-12
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 900

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neuropsychological Test Scores	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

Name	Time	Method
Brain Tissue	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.
Neurological Exam	Up to 20 Years	A thorough neurological exam will be performed once per year to evaluate neurological function.

Trial Locations

Locations (1)

University of Arizona, University Medical Center; 🇺🇸 Tucson, Arizona, United States