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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06179979
• Other study ID #: PET-PIB-1
• Status: Completed
• Start date: May 17, 2008
• Est. completion date: July 15, 2008

Study information

• Verified date: December 2023
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 15, 2008
• Est. primary completion date: July 15, 2008
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• current or previous treatments with neuroactive drugs;

• pregnancy or breastfeeding.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Cognitive Dysfunction

Intervention

Diagnostic Test:
• PET/CT with 11C-PiB
Subjects considered suitable will undergo a clinical and neuropsychological evaluation and a PET/CT study with intravenous administration of 11C-PIB.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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