NCT01421420

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
900

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
10.1 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
13.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

June 12, 2015

Status Verified

January 1, 2015

Enrollment Period

23.4 years

First QC Date

July 25, 2011

Last Update Submit

June 10, 2015

Conditions

Keywords

Alzheimer'sDementiaMild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Neurological Exam

    Up to 20 Years

  • Brain Tissue

    From date of entry until date of death assessed up to 20 years

Study Arms (4)

Alzheimer's Disease

Mild Cognitive Impairment

Other forms of Dementia, not AD

Normal Elderly Individuals

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with Alzheimer's disease, mild cognitive impairment, other forms of dementia, and normal elderly individuals.

You may qualify if:

  • For patients with MCI, or dementia, the presence of cognitive deficits including memory, language, and executive function.

You may not qualify if:

  • Presence of non-neurological medical conditions interfering with cognition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona, University Medical Center

Tucson, Arizona, 85724, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, saliva, brain tissue

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionMemory DisordersDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steven Z Rapcsak, M.D.

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 25, 2011

First Posted

August 22, 2011

Study Start

July 1, 2001

Primary Completion

December 1, 2024

Study Completion

July 1, 2025

Last Updated

June 12, 2015

Record last verified: 2015-01

Locations