The Comparative Effectiveness Dementia & Alzheimer's Registry (CEDAR)

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Multidomain precision medicine intervention

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Caroline E Carlton, B.A.; Phone Number: 212-746-2105; Email: cca4006@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Caroline E Carlton, B.A.; Phone Number: 212-746-2105; Email: cca4006@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Male and female patients will be recruited at the Alzheimer's Prevention Clinic, Weill Cornell Medicine Memory Disorders Program.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Alzheimer's Prevention Initiative Cognitive Composite (APCC) every 6 months	Composite Cognitive Battery (including NIH Toolbox Cognition Battery and other pen-and-paper neuropsychological tests).	every 6 months, for 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Cognitive Aging Composite (CAC) every 6 months	Composite Cognitive Battery, including neuropsychological tests related to non-pathological (age-related) cognitive decline.	every 6 months, for 18 months
Change from Baseline of Australian National University - Alzheimer's Disease Risk Score (ANU-ADRI) at 6 months	Measure longitudinal changes in a validated Alzheimer's risk scale (score range from -13 to 78) where higher scores confer higher risk	6 months
Change in Baseline on Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) Risk Score at 18 months	Measure longitudinal changes in a validated Alzheimer's risk scale (score range from 0 to 14) where higher scores confer higher risk	18 months
Change from Baseline on American College of Cardiology / American Heart Association Cardiovascular Risk Percentage at 18 months	Measure longitudinal changes in a validated cardiovascular risk scale (higher percentage confers higher risk).	18 months
Change from Baseline on Multi-Ethnic Study of Atherosclerosis (MESA) Risk Percentage at 18 months.	Measure longitudinal changes in a validated cardiovascular risk scale (higher percentage confers higher risk).	18 months
Change from Baseline in Cholesterol Biomarkers at 18 months	Change in blood serum levels of cholesterol (total, LDL, HDL) in mg/dL	18 months
Change from Baseline in Inflammatory Biomarkers at 18 months	Change in blood serum levels of hs-CRP, fibrinogen, Cystatin C in mg/dL	18 months
Change from Baseline in Metabolism Biomarkers at 18 months	Change in blood serum levels of HbA1c and HOMA-IR	18 months
Change from Baseline in Homocysteine at 18 months	Change in blood serum level of homocysteine	18 months
Change from Baseline in Vitamin D at 18 months	Change in blood serum level of Vitamin D	18 months

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Lisa Mosconi, Ph.D., Weill Medical College of Cornell University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2015
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 26, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Cognition Disorders; Dementia; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 1408015423

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No