Mild Congitive Impairment (MCI) MedDRA version: 14.1 Level: LLT Classification code 10050727 Term: RI scan System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: NA
Product Code: (R)-[N-metil-11C]-PK11195 (PK)
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: (R)-[N-metil-11C]-PK11195
Other d
Sponsors
IRCCS CENTRO SAN GIOVANNI DI DIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Male and female aged between 55-90 years; -Memory complains reflecting a change in cognition reported by patient or informant or clinician; -Presence of objective memory or other cognitive domain impairment; -General cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimer’s disease cannot be made by the site physician at the time of the screening visit; -Mini-Mental State Exam score between 24 and 30 (inclusive); -Clinical Dementia Rating = 0.5. Memory Box score must be at least 0.5; -Amnestic Mild Cognitive Impairment (MCI) (pure amnestic or multidomain); -At least 5 grades education. -Written informed consent 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 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85
Exclusion criteria
Exclusion criteria: -Visual and auditory acuity inadequate for neuropsychological testing; -History of significant neurological or psychiatric illnesses or presence of other diseases precluding enrolment; -The chronic use of anti-inflammatory drugs -Female subjects of child-bearing potential with a positive pregnancy test; -Female subjects who are nursing;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main study objective is to expand the investigation of diagnostic and monitoring basic markers (structural MRI, tau/abeta42 levels in the CSF, FDG PET) to advanced marker, such as molecular imaging. We will use the [11C]PK11195 (pk) that represents a validated and specific PET radioligand marker of activated microglia. Other advanced techniques will allow to collect advanced markers: Diffusion Tensor Imaging Sequences; resting functional magnetic resonance and protein p53;Secondary Objective: •To set up a large dataset of MCI patients providing clinical, imaging, and biological data (basic markers) collected at baseline in a standardized and centralized fashion, including clinical data relative to disease progression after a 12-month follow-up. •To identify the combination of basic markers with the highest accuracy for diagnosing of AD at the MCI stage. •To identify which combination of basic markers is more sensitive to disease progression. •To evaluate the incidence of Adverse events reported during all the study and until 7 days after PK administration as reported by phone. •To evaluate the vital signs at baseline (before and after radiotracer administration) and at 12-month follow-up visit;Primary end point(s): The main study objective is to expand the investigation of diagnostic and monitoring basic markers (structural MRI, tau/abeta42 levels in the CSF, FDG PET) to advanced marker, such as molecular imaging. We will use the [11C]PK11195 (pk) that represents a validated and specific PET radioligand marker of activated microglia. Other advanced techniques will allow to collect advanced markers: Diffusion Tensor Imaging Sequences; resting functional magnetic resonance and protein p53;Timepoint(s) of evaluation of this end point: end of clinical trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •To set up a large dataset of MCI patients providing clinical, imaging, and biological data (basic markers) collected at baseline in a standardized and centralized fashion, including clinical data relative to disease progression after a 12-month follow-up. •To identify the combination of basic markers with the highest accuracy for diagnosing of AD at the MCI stage. •To identify which combination of basic markers is more sensitive to disease progression. •To evaluate the incidence of Adverse events reported during all the study and until 7 days after PK administration as reported by phone. •To evaluate the vital signs at baseline (before and after radiotracer administration) and at 12-month follow-up visit;Timepoint(s) of evaluation of this end point: end of clinical trial | — |
Countries
Italy
Outcome results
None listed