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Enrolling by Invitation

NCT Number: NCT03687710

The Comparative Effectiveness Dementia & Alzheimer's Registry

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Weill Cornell Medicine

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multidomain precision medicine intervention

Behavioral

Participants will receive individualized evidence-based multidomain interventions (education, pharmacologic, non-pharmacologic) in the setting of routine outpatient clinical care.

Primary outcomes

  1. Change from Baseline in Alzheimer's Prevention Initiative Cognitive Composite (APCC) every 6 months

    Time frame: every 6 months, for 18 months

    Composite Cognitive Battery (including NIH Toolbox Cognition Battery and other pen-and-paper neuropsychological tests).

Secondary outcomes

  1. Change from Baseline in Cognitive Aging Composite (CAC) every 6 months

    Time frame: every 6 months, for 18 months

    Composite Cognitive Battery, including neuropsychological tests related to non-pathological (age-related) cognitive decline.

  2. Change from Baseline of Australian National University - Alzheimer's Disease Risk Score (ANU-ADRI) at 6 months

    Time frame: 6 months

    Measure longitudinal changes in a validated Alzheimer's risk scale (score range from -13 to 78) where higher scores confer higher risk

  3. Change in Baseline on Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) Risk Score at 18 months

    Time frame: 18 months

    Measure longitudinal changes in a validated Alzheimer's risk scale (score range from 0 to 14) where higher scores confer higher risk

  4. Change from Baseline on American College of Cardiology / American Heart Association Cardiovascular Risk Percentage at 18 months

    Time frame: 18 months

    Measure longitudinal changes in a validated cardiovascular risk scale (higher percentage confers higher risk).

  5. Change from Baseline on Multi-Ethnic Study of Atherosclerosis (MESA) Risk Percentage at 18 months.

    Time frame: 18 months

    Measure longitudinal changes in a validated cardiovascular risk scale (higher percentage confers higher risk).

  6. Change from Baseline in Cholesterol Biomarkers at 18 months

    Time frame: 18 months

    Change in blood serum levels of cholesterol (total, LDL, HDL) in mg/dL

  7. Change from Baseline in Inflammatory Biomarkers at 18 months

    Time frame: 18 months

    Change in blood serum levels of hs-CRP, fibrinogen, Cystatin C in mg/dL

  8. Change from Baseline in Metabolism Biomarkers at 18 months

    Time frame: 18 months

    Change in blood serum levels of HbA1c and HOMA-IR

  9. Change from Baseline in Homocysteine at 18 months

    Time frame: 18 months

    Change in blood serum level of homocysteine

  10. Change from Baseline in Vitamin D at 18 months

    Time frame: 18 months

    Change in blood serum level of Vitamin D

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Acronym: CEDAR

Important dates

Study start
2015
Primary completion
2028
Study completion
2028
First posted
Sep 27, 2018
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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