Alzheimer's Disease Core Center

Mild Cognitive Impairment Clinical Trial

— ADCC  

Official title:

Arizona Alzheimer's Disease Core Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01421420
• Other study ID #: P30AG019610
• Secondary ID: P30AG019610
• Status: Recruiting
• Phase: N/A
• First received: July 25, 2011
• Last updated: June 10, 2015
• Start date: July 2001
• Est. completion date: July 2025

Study information

• Verified date: January 2015
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 900
• Est. completion date: July 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age-Related Memory Disorders
• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Memory Disorders
• Mild Cognitive Impairment

Locations

Country	Name	City	State
United States	University of Arizona, University Medical Center	Tucson	Arizona

Sponsors (6)

Lead Sponsor	Collaborator
University of Arizona	Banner Health, Barrow Neurological Foundation, Mayo Clinic, National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological Test Scores	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.	Up to 20 years	No
Secondary	Neurological Exam	A thorough neurological exam will be performed once per year to evaluate neurological function.	Up to 20 Years	No
Secondary	Brain Tissue	A brain autopsy will be performed upon the participant's death to establish histological diagnosis.	From date of entry until date of death assessed up to 20 years	No