NCT04163276

Brief Summary

This study evaluate the interest to create a new database of PET digital brain exams in population of 50 years and over of patients. Half of patients with no abnormal brain metabolism while the other half patients with Alzheimer's disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2008

Completed
11.9 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 14, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

November 27, 2020

Status Verified

November 1, 2020

Enrollment Period

12.4 years

First QC Date

November 12, 2019

Last Update Submit

November 25, 2020

Conditions

Keywords

neurodegenerative diseasedigital brain PET examdatabase

Outcome Measures

Primary Outcomes (1)

  • data base analysis

    Comparison of Z-scores from PET/CT of the quantitative analysis of patients without abnormality of the brain metabolism and of typical Alzheimer patients (brain metabolism of the regions involved in Alzheimer's disease), calculated with 2 databases: * An analogue database consisting of 18F-FDG PET/CT without brain metabolism abnormalities in patients aged 50 and over; * A digital database, consisting of 18F-FDG PET/CT without brain metabolism abnormalities in patients aged 50 and over

    1 hour

Study Arms (2)

Group 1

20 patients without anomaly of brain metabolism

Diagnostic Test: 18F FDG PET exam

Group 2

20 patients with Alzheimer's disease

Diagnostic Test: 18F FDG PET exam

Interventions

18F FDG PET examDIAGNOSTIC_TEST

All patients have received 18F-FDG PET/CT in nuclear medicine

Group 1Group 2

Eligibility Criteria

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

The population will be enrolled thank to a listing of patient available in nuclear médicine unit. This listing cntain patient who performed a 18F-FDG brain TEP in nuclear médicine unit between 2010 and 2019.

You may qualify if:

  • Having performed a 18F-FDG cerebral PET/CT exam as part of an Alzheimer's assessment at the Nuclear Medicine department of NANCY, sent by the Geriatric Department
  • Patient who has received complete information on the organization of the research and who has not objected to the exploitation of this data
  • Patient affiliated to a social security

You may not qualify if:

  • patient who has received complete information on the organization of the research and who has objected to the exploitation of this data
  • For patients with no abnormality in 18F-FDG PET, Mini Mental State Examination (MMSE) \<25 or clinically diagnosed neurodegenerative pathology
  • For patients with typical hypometabolism of 18F-FDG PET/CT, biology of cerebrospinal fluid not in favor of Alzheimer's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Verger Antoine, PhD

    Central Hospital, Nancy, France

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

November 14, 2019

Study Start

January 2, 2008

Primary Completion

June 6, 2020

Study Completion

October 1, 2020

Last Updated

November 27, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations