The Comparative Effectiveness Dementia & Alzheimer's Registry

Alzheimer Disease Clinical Trial

— CEDAR  

Official title:

The Comparative Effectiveness Dementia & Alzheimer's Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03687710
• Other study ID #: 1408015423
• Status: Active, not recruiting
• Start date: February 16, 2015
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 452
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change from Baseline in Cholesterol Biomarkers at 18 months	Change in blood serum levels of cholesterol (total, LDL, HDL) in mg/dL	18 months
Secondary	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
Secondary	Change from Baseline in Metabolism Biomarkers at 18 months	Change in blood serum levels of HbA1c and HOMA-IR	18 months
Secondary	Change from Baseline in Homocysteine at 18 months	Change in blood serum level of homocysteine	18 months
Secondary	Change from Baseline in Vitamin D at 18 months	Change in blood serum level of Vitamin D	18 months