Alzheimer's DiseaseADCCNCT01421420
Alzheimer's Disease Core Center
An observational study of Alzheimer's Disease and Mild Cognitive Impairment, run by University of Arizona at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment, Age-Related Memory Disorders
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with Alzheimer's disease, mild cognitive impairment, other forms of dementia, and normal elderly individuals.
Who may be able to join
- For patients with MCI, or dementia, the presence of cognitive deficits including memory, language, and executive function.
Who cannot join
- Presence of non-neurological medical conditions interfering with cognition.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Arizona, University Medical Center
Tucson, Arizona, 85724
Kim Corley, B.A., 520-626-3746, kgcorley@email.arizona.edu
Steven Z Rapcsak, M.D.
About this study
Official title: Arizona Alzheimer's Disease Core Center
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.
Read the 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.
- Keywords
- Alzheimer's, Dementia, Mild Cognitive Impairment
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Memory Disorders, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's Disease | Not described | |
| Mild Cognitive Impairment | Not described | |
| Other forms of Dementia, not AD | Not described | |
| Normal Elderly Individuals | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 20 years
Secondary outcomes (2)
Neurological Exam
A thorough neurological exam will be performed once per year to evaluate neurological function.
Measured: Up to 20 Years
Brain Tissue
A brain autopsy will be performed upon the participant's death to establish histological diagnosis.
Measured: From date of entry until date of death assessed up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startJul 2001
- Primary completionDec 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Banner Health, Barrow Neurological Foundation, Mayo Clinic, National Institute on Aging (NIA), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Steven Z Rapcsak, M.D., Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421420
- Sponsor's protocol ID
- P30AG019610
- Other IDs
- P30AG019610
- Acronym
- ADCC
- Status last verified
- Jan 2015
- First submitted
- 25 Jul 2011
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arizona Alzheimer's Disease Core Center
- ClinicalTrials.gov ID
- NCT01421420
- Acronym / sponsor ID
- ADCC / P30AG019610
- Keywords
- Alzheimer's, Dementia, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Banner Health, Barrow Neurological Foundation, Mayo Clinic, National Institute on Aging (NIA), National Institutes of Health (NIH)
- Study start
- Jul 2001
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease | – | – |
| Mild Cognitive Impairment | – | – |
| Other forms of Dementia, not AD | – | – |
| Normal Elderly Individuals | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with Alzheimer's disease, mild cognitive impairment, other forms of dementia, and normal elderly individuals.
Key inclusion criteria (1 listed)
- For patients with MCI, or dementia, the presence of cognitive deficits including memory, language, and executive function.
Key exclusion criteria (1 listed)
- Presence of non-neurological medical conditions interfering with cognition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Neurological Exam
Time frame: Up to 20 Years
Brain Tissue
Time frame: From date of entry until date of death assessed up to 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University of Arizona, University Medical Center
Tucson, United States
Steven Z Rapcsak, M.D. principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Mild Cognitive Impairment, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological Test Scores (time frame: Up to 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2015.