Mild Cognitive ImpairmentINTERCEPTORNCT03834402
INTERCEPTOR Project: From MCI to Dementia
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MCI subjects
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
In the next 8 years a number of phase 2-3 trials will end up which utilize experimental drugs possibly disease modifying for Alzheimer Dementia. They target different disease stages: mild-moderate AD, 'early' AD, MCI prodromic to AD (MCI + for biomarkers heralding progression to AD), pre-symptomatic AD in pathogenetic gene mutation carriers of familiar AD forms. 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. Since the new drugs -if effective- will carry both elevated unit costs and not marginal side-effects, they should be administered selectively to those MCI with a severely high risk of conversion (i.e. 90% or more) and particularly to those with a highrisk of rapid conversion (1-2 years from diagnosis of the MCI condition).
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 questionnaire, screening test (MMSE), extended neuropsychological evaluation (incl. 2 episodic memory tests, language test, visuo-spatial abilities evaluation, behavioural scales, functional scales (Annex), full neurological examination. CDR must be 0.5. Atypical types of clinical presentations must be particularly considered (i.e. non amnesic debut) for a differential diagnosis where the role of biomarkers is pivotal.
In Italy, according to a recent study, an MCI prevalence of 5.9% has been evaluated in over 60 yrs population, with an increase of 4.5% between 60 \& 69 yrs, of 5.8% between 70 \& 79 yrs, and up to 7.1% in the 80 - 89 yrs range. On this epidemiological basis about 735.000 MCI cases are estimated for 2016in the resident Italian population. Multicentric non therapeutic cohort study in subjects fulfilling the MCI "core" criteria as defined by the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. The study design reflect a longitudinal cohort study 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.
All the medications at baseline are allowed without modifications for the whole protocol except for urgencies.
Neuropsychological follow-up tests will be carried out at 6 months intervals (total 7 from T0= baseline to T6= 42 months).
Within 60 days from T0 biomarkers must be carried out/collected including:
MMSE \& DRF - FCSRT) DNA extraction and ApoE typing Lumbar Puncture for Beta/Tau metabolites EEG for brain connectivity with graph theory MRI + hippocampal volumetry (18F)FDG-PET
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- Mild Cognitive Impairment, Alzheimer Disease
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
MCI converting to AD
Percentage of enrolled patients that convert from MCI to Alzheimer's disease within 3.0 years.
Measured: 3 years
Secondary outcomes (1)
PREDICTING BIOMARKERS
Identify the biomarker or the set of biomarker that predict, using statistical techniques, in the most precise way the "conversion from MCI to AD" event.
Measured: 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 May 2019
- Primary completion1 Oct 2019
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy, Agenzia Italiana del Farmaco
- Responsible party
- Principal investigator, Paolo Maria Rossini, Catholic University of the Sacred Heart
- Investigators
- Paolo Maria Rossini, Prof, Principal investigator, Catholic University of Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834402
- Sponsor's protocol ID
- 2251
- Acronym
- INTERCEPTOR
- Status last verified
- Feb 2024
- First submitted
- 10 Jan 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be at the disposal of the recruiting centers involved in the study
Publications
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.
PubMed 21514249Appollonio 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.
PubMed 15995827Arevalo-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.
PubMed 25740785Lombardo 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.
PubMed 39049042
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03834402
- Acronym / sponsor ID
- INTERCEPTOR / 2251
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- Mild Cognitive Impairment, Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy, Agenzia Italiana del Farmaco
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the next 8 years a number of phase 2-3 trials will end up which utilize experimental drugs possibly disease modifying for Alzheimer Dementia. They target different disease stages: mild-moderate AD, 'early' AD, MCI prodromic to AD (MCI + for biomarkers heralding progression to AD), pre-symptomatic AD in pathogenetic gene mutation carriers of familiar AD forms. 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. Since the new drugs -if effective- will carry both elevated unit costs and not marginal side-effects, they should be administered selectively to those MCI with a severely high risk of conversion (i.e. 90% or more) and particularly to those with a highrisk of rapid conversion (1-2 years from diagnosis of the MCI condition).
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 questionnaire, screening test (MMSE), extended neuropsychological evaluation (incl. 2 episodic memory tests, language test, visuo-spatial abilities evaluation, behavioural scales, functional scales (Annex), full neurological examination. CDR must be 0.5. Atypical types of clinical presentations must be particularly considered (i.e. non amnesic debut) for a differential diagnosis where the role of biomarkers is pivotal.
In Italy, according to a recent study, an MCI prevalence of 5.9% has been evaluated in over 60 yrs population, with an increase of 4.5% between 60 \& 69 yrs, of 5.8% between 70 \& 79 yrs, and up to 7.1% in the 80 - 89 yrs range. On this epidemiological basis about 735.000 MCI cases are estimated for 2016in the resident Italian population. Multicentric non therapeutic cohort study in subjects fulfilling the MCI "core" criteria as defined by the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. The study design reflect a longitudinal cohort study 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.
All the medications at baseline are allowed without modifications for the whole protocol except for urgencies.
Neuropsychological follow-up tests will be carried out at 6 months intervals (total 7 from T0= baseline to T6= 42 months).
Within 60 days from T0 biomarkers must be carried out/collected including:
MMSE \& DRF - FCSRT) DNA extraction and ApoE typing Lumbar Puncture for Beta/Tau metabolites EEG for brain connectivity with graph theory MRI + hippocampal volumetry (18F)FDG-PET
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MCI subjects
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MCI converting to AD
Time frame: 3 years
Percentage of enrolled patients that convert from MCI to Alzheimer's disease within 3.0 years.
1 secondary outcome
PREDICTING BIOMARKERS
Time frame: 4.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 21514249Albert 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.
- Background: PubMed 15995827Appollonio 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.
- Background: PubMed 25740785Arevalo-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.
- Derived from this study: PubMed 39049042Lombardo 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.
- Individual participant dataSharing planned: No. IPD will only be at the disposal of the recruiting centers involved in the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paolo Maria Rossini, Prof principal investigator
Catholic University of Sacred Heart
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Alzheimer Disease, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MCI converting to AD (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03834402, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.