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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03687710
Recruitment Status : Active, not recruiting
First Posted : September 27, 2018
Last Update Posted : October 29, 2021
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Alzheimer Disease Mild Cognitive Impairment 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: The Comparative Effectiveness Dementia & Alzheimer's Registry
Actual Study Start Date : February 16, 2015
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687710


Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Richard Isaacson, M.D. Weill Medical College of Cornell University
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03687710    
Other Study ID Numbers: 1408015423
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: October 29, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders