PET Study With 11 C-PIB to Evaluate Amyloid Protein Deposits in Mild Cognitive Disorder, Alzheimer's Disease and Early Frontotemporal Degeneration.

Preclinical and clinical data have demonstrated the ability of the 11C-PIB tracer to selectively bind accumulations of amyloid protein, a neuropathological marker characteristic of the neurodegenerative pathologies covered by this study.

The validation in larger groups of patients, and the comparison between the different clinical syndromes included in the spectrum, will allow the diagnostic and prognostic potential of the tracer to be evaluated, with important consequences for the clinical management of patients.

In particular, the tracer could play a central role in the clinical management of patients with neurodegenerative diseases and cognitive impairment.

Numerous pharmacological trials are currently underway, worldwide, for the validation of anti-amyloid drugs. In the future we could think about early monitoring with imaging of the effectiveness of the treatment.

T he FDG PET technique can be of great help in obtaining relationships between radiation damage to the brain and possibly neurological and neuropsychological deficits associates.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Diagnostic test: PET/CT with 11C-PiB

• Study Type: Observational
• Enrollment (Actual): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Adult patients with neurodegenerative diseases will be included: with mild cognitive disorder, Alzheimer's dementia and early temporal frontal degeneration.

Description

Inclusion Criteria:

• Alzheimer's diagnosis according to the diagnostic criteria in use.

Exclusion Criteria:

• current or previous treatments with neuroactive drugs;
• pregnancy or breastfeeding.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PET/CT with 11C-PiB to characterize amyloid protein deposits in patients with neurodegenerative diseases.	Comparative evaluation of the accumulation of amyloid protein in the various neurodegenerative conditions included with attention to the specificity of the tracer as an element of differential diagnosis.	2 years

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2008
• Primary Completion (Actual): July 15, 2008
• Study Completion (Actual): July 15, 2008

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Cognitive Dysfunction; Cognition Disorders
• Other Study ID Numbers: PET-PIB-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No