NCT05405075

Brief Summary

The Arizona Alzheimer's Disease Research Center (ADRC) is the National Institute on Aging's (NIA's) first statewide AD Center (ADC), the only ADC in the Southwestern United States, and a leading example of statewide collaboration in biomedical research. It capitalizes on Arizona's strengths in brain imaging, genomics, computer science and biomathematics, the basic, cognitive and behavioral neurosciences, clinical, and neuropathological studies of AD, the discovery and evaluation of investigational treatments, and the study of normal cognitive aging.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
550

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Completed
Last Updated

August 19, 2024

Status Verified

July 1, 2024

Enrollment Period

4.7 years

First QC Date

March 4, 2022

Last Update Submit

August 16, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive Status

    The ADRC uses a prospective, standardized, and longitudinal clinical evaluation of participants to determine their cognitive status. This includes tests that assess short and long term memory, ability to complete daily tasks, and processing of information.

    12 months

Eligibility Criteria

Age40 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The Clinical Core maintains a target of 550 participants at all stages of the aging-dementia spectrum including 400 normal controls and 150 participants with MCI, probable AD dementia and other dementias. Embedded within these diagnostic categories are defined Latino and Native American cohorts. Participants will be referred to the ADRC from varying sources including, but not limited to, clinic referrals, community outreach programs, general advertising, national registries, and other sites within the consortium. Participants eligible for enrollment and those completing annual follow-up are discussed in frequent diagnostic consensus conferences. All undergo a standardized neuropsychological and neurological battery of tests at entry and annual tests at all sites.

You may qualify if:

  • Cognitively normal persons, individuals with mild cognitive impairment or dementia who are at least 40 years of age.
  • Willing to undergo health and cognitive assessments, and collection and banking of blood with venipuncture for genetic research, biomarker research, and DNA banking.

You may not qualify if:

  • \. Participants whose diagnosis is unclear and confounded by multiple possible factors are excluded. Participants with diagnoses of non-AD dementias are not excluded.
  • \. Participants whose primary diagnosis is cognitive impairment due to a penetrating or single severe closed head injury, multiple sclerosis, brain tumor, metabolic or toxic encephalopathy, post-infectious (e.g., viral encephalitis, bacterial meningitis), paraneoplastic, primary psychiatric illness, or otherwise not deemed relevant to the intent of the Alzheimer Disease Center program are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Banner Alzheimer's Institute

Phoenix, Arizona, 85006, United States

RECRUITING

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

RECRUITING

Mayo Clinic

Scottsdale, Arizona, 85259, United States

RECRUITING

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

RECRUITING

Banner Alzheimer's Institute - Tucson

Tucson, Arizona, 85718, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2022

First Posted

June 6, 2022

Study Start

October 1, 2021

Primary Completion

June 30, 2026

Study Completion

June 30, 2026

Last Updated

August 19, 2024

Record last verified: 2024-07

Locations