study of neuroinflammation in pathologies like Alzheimer, mild cognitive impairment, dementia and SLA

• Register: EUCTR
• Last refreshed on: 27 January 2014
• Main ID: EUCTR2012-004328-40-IT
• Date of registration: 23/11/2012
• Prospective Registration: Yes
• Primary sponsor: OSPEDALE S. RAFFAELE DI MILANO
• Public title: study of neuroinflammation in pathologies like Alzheimer, mild cognitive impairment, dementia and SLA
• Scientific title: IMAGING OF NEUROINFLAMMATION IN NEURODEGENERATIVE DISEASES
• Date of first enrolment: 01/03/2013
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004328-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1

Countries of recruitment

Italy

Contacts

• Name: Medicina Nucleare
• Affiliation: Ospedale San Raffaele

• Name: Medicina Nucleare
• Affiliation: Ospedale San Raffaele

Key inclusion & exclusion criteria

Inclusion criteria:
patients with neurodegenerative diseases (mild cognitive impairment, Alzheimer's disease, frontotemporal dementia, amyotrophic lateral sclerosis SLA) on a sporadic or genetic base; male and female patients aged over 18 years.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion criteria:
focal brain , physical, psychiatric or metabolic disorders which might otherwise explain the cognitive and / or motor impairment.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

mild cognitive impairment, Alzheimer disease,frontotemporal dementia, SLA
MedDRA version: 14.1 Level: LLT Classification code 10050727 Term: RI scan System Organ Class: 100000004848

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: NA
Product Code: (R)-[N-metil-11C1-PK11195(PK)
Pharmaceutical Form: Solution for injection
Current Sponsor code: (R)-[N-metil-11C]-PK11195
Concentration unit: MBq megabecquerel(s)
Concentration type: up to
Concentration number: 185-

Primary Outcome(s)

Primary end point(s): to use the radiotracer [11C] PK-PET imaging as early biomarker applicable in the clinical field, with the PET methodology, in neurodegenerative diseases

Main Objective: to use the radiotracer [11C] PK-PET imaging as early biomarker applicable in the clinical field, with the PET methodology, in neurodegenerative diseases

Secondary Objective: (i) to identify novel mechanisms of regulation and function of microglia under various conditions (inflammatory stimuli; neurodegenerative and -regenerative model systems); (ii) to identify and implement new targets for activated microglia, which may serve for diagnostic (imaging) and therapeutic purposes; (iii) to design new molecular probes (tracers) for these novel targets and to implement and validate them in in vivo model systems and patients; (iv) to image and quantify modulated microglia activity in patients undergoing immune therapy for cognitive impairment and relate findings to clinical outcome.

Timepoint(s) of evaluation of this end point: at the end of the study

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: at the end of the study

Secondary end point(s): i) identificare nuovi meccanismi di regolazione e la funzione della microglia in varie condizioni (stimoli infiammatori, sistemi modello di tipo neurodegenerativo e rigenerativo); (ii) individuare ed implementare nuovi obiettivi per la microglia attivata, che possano essere utili per la diagnostica (imaging) e a fini terapeutici; (iii) progettare per questi obiettivi nuovi nuovi traccianti da validare in sistemi modello in vivo e nei pazienti; (iv) quantificare l'attività modulata della microglia in pazienti sottoposti a terapia immunitaria per peggioramento cognitivo e correlati di esito clinico

Secondary ID(s)

INMINDFP7-HEALTH-2011-two-stage

Source(s) of Monetary Support

Programma Europeo FP7-HEALTH-2011-two-stage