The Comparative Effectiveness Dementia & Alzheimer's Registry

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Comparative Effectiveness Dementia & Alzheimer's Registry

Conditions
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Alzheimer Disease, Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Multidomain precision medicine intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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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 |