NCT03687710

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
452

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Feb 2015Jun 2028

Study Start

First participant enrolled

February 16, 2015

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

13.4 years

First QC Date

September 6, 2018

Last Update Submit

March 26, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

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

    every 6 months, for 18 months

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

    6 months

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

    18 months

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

    18 months

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

    18 months

  • +5 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female patients will be recruited at the Alzheimer's Prevention Clinic, Weill Cornell Medicine Memory Disorders Program.

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Schantel Williams, MPH, RN

    Program Director of Alzheimer's Prevention Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2018

First Posted

September 27, 2018

Study Start

February 16, 2015

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations