NCT06180252

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2004

Typical duration for all trials

Status
completed

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

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2008

Completed
15.9 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 22, 2023

Completed
Last Updated

December 22, 2023

Status Verified

December 1, 2023

Enrollment Period

3.7 years

First QC Date

December 12, 2023

Last Update Submit

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

PET with 11C MP4DIAGNOSTIC_TEST

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

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

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