NCT03834402Completed
INTERCEPTOR Project: From MCI to Dementia
Interceptor Project: On Early Diagnosis Of The Prodromal Stage Of Alzheimer Disease. The Progression From Mild Cognitive Impairment (Mci) To Dementia: The Role Of Biomarkers In Early Interception Of Patients Candidate For Prescription Of Future Disease-Modifying Drugs
Source: ClinicalTrials.gov · Last updated 7 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 500 (actual)
- First submitted
- 10 Jan 2019
- Start date
- 1 May 2019
- Primary completion date
- 1 Oct 2019
- Lead sponsor
- Catholic University of the Sacred Heart
- Diseases
- Alzheimer disease
- NCT number
- NCT03834402
What you commit to
- Study type: Observational
- Participants enrolled: 500
- From 1 May 2019 to the primary completion date, 1 Oct 2019
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- history of cerebrovascular disease (i.e. stroke episodes), alcohol abuse, severe medical disorders associated with cognitive impairment (organ failures, endocrine disorders, in particular thyroid disease and B12/folates deficiency); neuroimaging evidence of other potential causes of cognitive decline (e.g. subdural haematoma, malignancy etc.); chronic treatment with psychotropic drugs; women in reproductive age;
- use of drugs potentially affecting cognitive function, according to the investigator's judgement;
- subjects are not allowed to participate in any trial with experimental drug;
- Patients who refuse to or cannot temporarily interrupt antiplatelet or anticoagulant therapy 14 days prior to sampling visit.
Other illness
- contraindications for Magnetic Resonance Imaging (MRI): pacemaker; spinal stimulators; defibrillator; any other condition incompatible with MRI acquisition;
- HIV infection;
Age
- history of malignancy \< 5 years;
Other
- presence of spinal malformations or any other contraindications to lumbar puncture, according to the investigator's judgement;
Who the study is looking for
- age between 50 and 85 years;
- age and education corrected Mini Mental State Examination score equal or superior to 24/30;
- Clinical Dementia Rating (CDR) global score of 0.5;
- concerns about cognitive modifications, expressed as subjective complaints by the subject, or by impression by a close acquaintance or an expert clinician;
- defective performance with reference to age and education matched controls in one cognitive domain (memory, executive function, attention, language, visuospatial function): if repeated assessments are available, evidence of performance decline;
- preserved functional autonomy: the subject remains fully independent, even if specific performances may be slower, less efficient than usual level, with occasional errors;
- no dementia: the cognitive modifications do not significantly hamper social function or work activities.
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico Agostino Gemelli Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.