NCT07420075

Brief Summary

The design is an open-ended, prospective, observational, (non-interventional) registry for subjects with mild cognitive impairment (MCI), early symptomatic Alzheimer's disease, Alzheimer's disease, or dementia with clinical suspicion of Alzheimer's disease under the care of a neurologist, psychiatrist, geriatrician or other qualified provider. Longitudinal data are collected from subjects, their care partner(s), and their treating healthcare provider during routine clinical encounters using a structured and standardized data collection method. Approximately 2,000 subjects, with no defined upper limit, across around 75 clinical sites worldwide will be recruited.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
897mo left

Started Nov 2025

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 Progress1%
Nov 2025Dec 2099

Study Start

First participant enrolled

November 24, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
73.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2099

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2099

Last Updated

February 19, 2026

Status Verified

December 1, 2025

Enrollment Period

74.2 years

First QC Date

February 4, 2026

Last Update Submit

February 12, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Alzheimer Disease Epidemiology and presentation

    The major clinical outcome include an assessment of the epidemiology of Alzheimer's Disease; to better understand the presentation and natural history.

    Every 6 months for 10 years

  • Alzheimer Disease management, and outcomes

    The major clinical outcome include an assessment of the epidemiology of Alzheimer Disease; to better understand the management and outcomes.

    Every 6 months for 10 years

Eligibility Criteria

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

Subjects enrolled in this registry will be treated according to routine clinical care; treatments are prescribed at the provider's discretion and the decision to treat the subject with a drug is made prior to and independently of study participation. The clinician will determine subject visit schedules according to routine practice, patient needs,and local standard of care (SoC)

You may qualify if:

  • To be eligible to participate in this registry, an individual must meet all the following criteria (determined by the investigator):
  • Has been diagnosed with mild cognitive impairment (MCI), early symptomatic Alzheimer's disease, Alzheimer's disease, or dementia with clinical suspicion of Alzheimer's disease.
  • Subject is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment.
  • Has care partner(s) willing to participate as a source of information who maintains regular contact with the subject (defined as at least ten hours per week), will accompany the subject to the clinic visits, has attained the legal age for consent under the applicable law of jurisdiction in which the research is being conducted at the time of consent, and is willing and able to provide informed consent as the care partner.
  • Subject has the ability to understand the purpose, risks, and voluntariness of Registry participation and is willing and able to provide informed consent
  • For US subjects only, must be willing and able to provide Personally Identifiable Information (full legal name, sex at birth, date of birth, home address zip/postal code, and social security number at a minimum).
  • Has been prescribed (and intends to initiate) a commercially available therapy for the treatment of Alzheimer's disease (or symptoms of Alzheimer's disease) (Eligible Medication) at the time of enrollment.
  • Note: Participation in the registry will not interfere with the standard of care provided by the subject's treating clinician. Investigators retain independent clinical judgment in managing patient care.

You may not qualify if:

  • An individual who meets any of the following criteria will be excluded from participation in the registry:
  • Is participating or planning to participate in a double-blind randomized clinical trial for a MCI or AD.
  • Has been previously treated with an ATT prior to enrollment into the registry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CorEvitas, LLC

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 19, 2026

Study Start

November 24, 2025

Primary Completion (Estimated)

December 31, 2099

Study Completion (Estimated)

December 31, 2099

Last Updated

February 19, 2026

Record last verified: 2025-12

Locations