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INTERCEPTOR Project: From MCI to Dementia

NCT03834402 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2024-02-07

No results posted yet for this study

Summary

In the next years a number of phase 2-3 trials which utilize experimental drugs possibly disease modifying for Alzheimer Dementia will reach their conclusion. This dense clinical trials activity has triggered a fundamental question both from Patients and Scientific Communities and Health Authorities/Insurances: on which basis will the new drugs -if effective-be distributed to patients or at-risk population? This question mainly deals with the "MCI prodromal to AD"condition since the MCI population actually includes about 50% of those who will progress to AD (the real "prodromic to AD" MCI form) while the remaining 50% will never convert to AD.

The INTERCEPTOR project is focused on the prodromic AD condition (IWG2) or the MCI condition (NIA-AA) which form the neuropsychological point of view and is characterized by means of: cognitive questionnaires, screening test (MMSE), extended neuropsychological evaluation.

The study is an observational, longitudinal cohort one, in which the baseline clinical and biomarkers characteristics of the enrolled MCI subjects at baseline will be compared for those classified as "AD converters" after 3.0 years of follow-up with respect to those "non-converters". MCI subjects who will convert to other forms of dementia will be examined separately. It will be considered the conversion to Alzheimer's disease within 3.0 years after diagnosis of MCI, together with the assessment of those who remain in a stable condition and those who have a reversion to normal cognitive profile. People with MCI who convert to other forms of dementia will be considered separately. The biomarker or a set of biomarkers that can predict the conversion to Alzheimer's disease with higher accuracy will be evaluated.

Conditions

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • Agenzia Italiana del Farmaco

    collaborator OTHER_GOV

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Paolo Maria Rossini, Prof · Catholic University of Sacred Heart

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2019-10-01
Completion
2023-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03834402 on ClinicalTrials.gov