PET Study of Acetylcholine Esterase Activity in Alzheimer's Disease
1 other identifier
observational
30
0 countries
N/A
Brief Summary
The aim of this study is to understand regional variations in acetylcholine esterase activity in Alzheimer's disease. In this study the aim is to identify by PET the physiological values of the regional activity of acetylcholine esterase using the 11C PM4 tracer and to study by PET and 11C PM4 the brain activity of acetylcholine esterase in a group of patients with Alzheimer's disease, enrolled according to the inclusion and exclusion criteria. The PET data will be correlated with the clinical, neuropsychological and morphological data acquired by MRI and with the clinical-cognitive outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2004
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 12, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 29, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 29, 2008
CompletedFirst Submitted
Initial submission to the registry
December 12, 2023
CompletedFirst Posted
Study publicly available on registry
December 22, 2023
CompletedDecember 22, 2023
December 1, 2023
3.7 years
December 12, 2023
December 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
PET with 11C MP4 as a tracer to identify acetylcholine esterase values in patients with neurodegenerative diseases.
Development of a new PET method for the in vivo measurement of acetylcholine esterase activity at the cortical level to be used as an indicator of the presence of disease.
4 years
Interventions
Each subject will undergo a PET exam using 11C MP4 as a tracer. This is a specific ligand for the acetyl-choline esterase enzyme already used abroad both in healthy volunteers and in various patient groups.
Eligibility Criteria
Patients diagnosed with Alzheimer's disease who are eligible for therapy with acetylcholine esterase inhibitors but not yet undergoing treatment.
You may qualify if:
- patients diagnosed with Alzheimer's disease;
- patients must have undergone an instrumental morphological examination to exclude other neurological pathologies.
You may not qualify if:
- positive history of major head trauma;
- clinically active somatic diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele
Study Record Dates
First Submitted
December 12, 2023
First Posted
December 22, 2023
Study Start
May 12, 2004
Primary Completion
January 29, 2008
Study Completion
January 29, 2008
Last Updated
December 22, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share