Clinical trial NCT03687710: The Comparative Effectiveness Dementia & Alzheimer's Registry
Official title: The Comparative Effectiveness Dementia & Alzheimer's Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 452
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Change from Baseline in Alzheimer's Prevention Initiative Cognitive Composite (APCC) every 6 months
timeFrame: every 6 months, for 18 months
Secondary outcomes:
measure: Change from Baseline in Cognitive Aging Composite (CAC) every 6 months
timeFrame: every 6 months, for 18 months
measure: Change from Baseline of Australian National University - Alzheimer's Disease Risk Score (ANU-ADRI) at 6 months
timeFrame: 6 months
measure: Change in Baseline on Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CAIDE) Risk Score at 18 months
timeFrame: 18 months
measure: Change from Baseline on American College of Cardiology / American Heart Association Cardiovascular Risk Percentage at 18 months
timeFrame: 18 months
measure: Change from Baseline on Multi-Ethnic Study of Atherosclerosis (MESA) Risk Percentage at 18 months.
timeFrame: 18 months
measure: Change from Baseline in Cholesterol Biomarkers at 18 months
timeFrame: 18 months
measure: Change from Baseline in Inflammatory Biomarkers at 18 months
timeFrame: 18 months
measure: Change from Baseline in Metabolism Biomarkers at 18 months
timeFrame: 18 months
measure: Change from Baseline in Homocysteine at 18 months
timeFrame: 18 months
measure: Change from Baseline in Vitamin D at 18 months
timeFrame: 18 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Director of Alzheimer's Prevention Program
name: Lisa Mosconi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.