INTERCEPTOR Project: From MCI to Dementia

NCT03834402 | Completed

• 1 other identifier: 2251
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Mild Cognitive Impairment; Alzheimer Disease

Keywords

Mild Cognitive Impairment; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• MCI converting to AD

  Percentage of enrolled patients that convert from MCI to Alzheimer's disease within 3.0 years.

  3 years

Secondary Outcomes (1)

• PREDICTING BIOMARKERS

  4.5 years

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MCI subjects

You may qualify if:

• 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.

You may not qualify if:

• 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;
• history of malignancy \< 5 years;
• contraindications for Magnetic Resonance Imaging (MRI): pacemaker; spinal stimulators; defibrillator; any other condition incompatible with MRI acquisition;
• presence of spinal malformations or any other contraindications to lumbar puncture, according to the investigator's judgement;
• HIV infection;
• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead
• Ministry of Health, Italy: collaborator
• Agenzia Italiana del Farmaco: collaborator

Study Sites (1)

Policlinico Agostino Gemelli

Rome, 00168, Italy

Location

Related Publications (4)

• Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.

  PMID: 21514249 BACKGROUND

• Appollonio I, Leone M, Isella V, Piamarta F, Consoli T, Villa ML, Forapani E, Russo A, Nichelli P. The Frontal Assessment Battery (FAB): normative values in an Italian population sample. Neurol Sci. 2005 Jun;26(2):108-16. doi: 10.1007/s10072-005-0443-4.

  PMID: 15995827 BACKGROUND

• Arevalo-Rodriguez I, Smailagic N, Roque I Figuls M, Ciapponi A, Sanchez-Perez E, Giannakou A, Pedraza OL, Bonfill Cosp X, Cullum S. Mini-Mental State Examination (MMSE) for the detection of Alzheimer's disease and other dementias in people with mild cognitive impairment (MCI). Cochrane Database Syst Rev. 2015 Mar 5;2015(3):CD010783. doi: 10.1002/14651858.CD010783.pub2.

  PMID: 25740785 BACKGROUND

• Lombardo FL, Lorenzini P, Mayer F, Massari M, Piscopo P, Bacigalupo I, Ancidoni A, Sciancalepore F, Locuratolo N, Remoli G, Salemme S, Cappa S, Perani D, Spadin P, Tagliavini F, Redolfi A, Cotelli M, Marra C, Caraglia N, Vecchio F, Miraglia F, Rossini PM, Vanacore N; INTERCEPTOR Network. Development of a prediction model of conversion to Alzheimer's disease in people with mild cognitive impairment: the statistical analysis plan of the INTERCEPTOR project. Diagn Progn Res. 2024 Jul 25;8(1):11. doi: 10.1186/s41512-024-00172-6.

  PMID: 39049042 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

ApoE test

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Paolo Maria Rossini, Prof

  Catholic University of Sacred Heart

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: February 8, 2019
• Study Start: May 1, 2019
• Primary Completion: October 1, 2019
• Study Completion: December 31, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)