The Comparative Effectiveness Dementia & Alzheimer's Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multidomain precision medicine intervention.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Mild Cognitive Impairment. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
To evaluate the effectiveness of using clinical precision medicine to develop lifecourse interventions for Alzheimer's disease (AD) prevention and treatment. Anthropometrics, blood biomarkers (including genetics), and cognition will measured longitudinally to assess the comparative effectiveness of clinical care.
Detailed description
The Comparative Effectiveness Dementia \& Alzheimer's Registry (CEDAR) Project is a prospective, observational registry of adult patients at-risk for, or with, a diagnosis of dementia due to Alzheimer's disease (AD) or other neurodegenerative dementias. The purpose of this study is to develop a research repository, or database, for information collected during routine medical care of people with normal memory and family history of AD, or with memory loss or other changes in thinking. The registry will help generate empirical evidence that improves knowledge and informs care decisions about risk reduction for dementia due to AD, and about the effectiveness of a clinical precision medicine intervention. Using a life course approach to comparative effectiveness research will enable investigators to analyze the effects of evidence-based multidomain interventions on cognition, biomarkers of AD risk, and calculated AD risk across the pre-dementia spectrum of AD.
Interventions
- Behavioral Multidomain precision medicine intervention
Participants will receive individualized evidence-based multidomain interventions (education, pharmacologic, non-pharmacologic) in the setting of routine outpatient clinical care.
Primary outcome measures
- Change from Baseline in Alzheimer's Prevention Initiative Cognitive Composite (APCC) every 6 months [Time frame: every 6 months, for 18 months]
Secondary outcome measures (10)
- Change from Baseline in Cognitive Aging Composite (CAC) every 6 months [Time frame: every 6 months, for 18 months]
- Change from Baseline of Australian National University - Alzheimer's Disease Risk Score (ANU-ADRI) at 6 months [Time frame: 6 months]
- Change in Baseline on Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) Risk Score at 18 months [Time frame: 18 months]
- Change from Baseline on American College of Cardiology / American Heart Association Cardiovascular Risk Percentage at 18 months [Time frame: 18 months]
- Change from Baseline on Multi-Ethnic Study of Atherosclerosis (MESA) Risk Percentage at 18 months. [Time frame: 18 months]
- Change from Baseline in Cholesterol Biomarkers at 18 months [Time frame: 18 months]
- Change from Baseline in Inflammatory Biomarkers at 18 months [Time frame: 18 months]
- Change from Baseline in Metabolism Biomarkers at 18 months [Time frame: 18 months]
- Change from Baseline in Homocysteine at 18 months [Time frame: 18 months]
- Change from Baseline in Vitamin D at 18 months [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
- 18 years of age or older
- family history of Alzheimer's disease and no cognitive complaints OR subjective cognitive decline OR preclinical AD OR mild cognitive impairment due to AD or other conditions
Exclusion criteria
- none
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Weill Cornell Medicine — New York
Publications
- Isaacson RS, Ganzer CA, Hristov H, Hackett K, Caesar E, Cohen R, Kachko R, Melendez-Cabrero J, Rahman A, Scheyer O, Hwang MJ, Berkowitz C, Hendrix S, Mureb M, Schelke MW, Mosconi L, Seifan A, Krikorian R. The clinical practice of risk reduction for Alzheimer's disease: A precision medicine approach. Alzheimers Dement. 2018 Dec;14(12):1663-1673. doi: 10.1016/j.jalz.2018.08.004. Epub 2018 Nov 13. PMID 30446421
Identifiers
NCT: NCT03687710 · 1408015423