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Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease 18F-Florbetaben Positron Emission Tomography Study

Primary Purpose

Alzheimer Disease

Status

Terminated

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Florbetaben

About this trial

This is an interventional diagnostic trial for Alzheimer Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adult children (> 18 yo) of genetic Alzheimer?s disease patients with a known mutation in PSEN1, APP o PSEN2 genes and who are either cognitively normal (CDR=0) or have mild symptoms of cognitive decline (CDR 0.5 or 1)
According to the principal investigator, participants must be committed to participate and complete all study procedures.
Has signed the Informed Consent Form voluntarily to participate in the study

Exclusion Criteria:

Subjects that are not able to complete the study.
Any major disease or history of a major disease, especially hepatobilliar disease (AST /ALT ? 5 x ULN) or advanced renal insufficiency (creatinine ? 2 x ULN)
Current or previous history of alcohol abuse or epilepsy
Allergic to Florbetaben or any of its constituents
Multiple drug allergies and/or previous history of contrast allergy.
Pregnancy or breast feeding or planned pregnancy during the study period
Any disease or history of disease which, in the opinion of the investigator, can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)
Evidence for any other neurological or psychiatric disease

Sites / Locations

Hospital Clínic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

mutation carrier

mutation non-carrier

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals at risk of genetic Alzheimer?s disease.

Proportion of FAD mutation carriers that present positive uptake after FBB-PET through visual examination

Secondary Outcome Measures

Proportion of FAD mutation carriers presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.

Areas of significant difference (p<0,05) in regional SUVR between FAD mutation carriers and non-carriers.

Earliest age of positive FBB-PET in FAD mutation carriers.

Individual cortical areas with positive amyloid deposition at visual or semi-quantitative assessment

Full Information

NCT ID

NCT02362880

First Posted

February 9, 2015

Last Updated

April 9, 2021

Sponsor

Judit Pich Martínez

1. Study Identification

Unique Protocol Identification Number

NCT02362880

Brief Title

Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease 18F-Florbetaben Positron Emission Tomography Study

Official Title

Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease: 18F-Florbetaben Positron Emission Tomography Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Terminated

Why Stopped

On 15 January 2019, the sponsor decided to stop the study prematurely due to lack of patient recruitment because of supply problems with 18 F-Florbetaben.

Study Start Date

February 2015 (Actual)

Primary Completion Date

January 2019 (Actual)

Study Completion Date

January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Judit Pich Martínez

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main purpose of the study is to assess safety of a single dose of FBB followed by PET scan in individuals at risk of genetic Alzheimer's disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mutation carrier

Arm Type

Active Comparator

Arm Title

mutation non-carrier

Arm Type

Sham Comparator

Intervention Type

Radiation

Intervention Name(s)

Florbetaben

Intervention Description

single dose of Florbetaben followed by PET scan

Primary Outcome Measure Information:

Title

Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals at risk of genetic Alzheimer?s disease.

Time Frame

At baseline, when FBB-PET is performed.

Title

Proportion of FAD mutation carriers that present positive uptake after FBB-PET through visual examination

Time Frame

At baseline, when FBB-PET is performed.

Secondary Outcome Measure Information:

Title

Proportion of FAD mutation carriers presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.

Time Frame

baseline

Title

Areas of significant difference (p<0,05) in regional SUVR between FAD mutation carriers and non-carriers.

Time Frame

baseline

Title

Earliest age of positive FBB-PET in FAD mutation carriers.

Time Frame

baseline

Title

Individual cortical areas with positive amyloid deposition at visual or semi-quantitative assessment

Time Frame

baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult children (> 18 yo) of genetic Alzheimer?s disease patients with a known mutation in PSEN1, APP o PSEN2 genes and who are either cognitively normal (CDR=0) or have mild symptoms of cognitive decline (CDR 0.5 or 1) According to the principal investigator, participants must be committed to participate and complete all study procedures. Has signed the Informed Consent Form voluntarily to participate in the study Exclusion Criteria: Subjects that are not able to complete the study. Any major disease or history of a major disease, especially hepatobilliar disease (AST /ALT ? 5 x ULN) or advanced renal insufficiency (creatinine ? 2 x ULN) Current or previous history of alcohol abuse or epilepsy Allergic to Florbetaben or any of its constituents Multiple drug allergies and/or previous history of contrast allergy. Pregnancy or breast feeding or planned pregnancy during the study period Any disease or history of disease which, in the opinion of the investigator, can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function) Evidence for any other neurological or psychiatric disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raquel Sánchez

Organizational Affiliation

Hospital Clinic of Barcelona

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Clínic de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease 18F-Florbetaben Positron Emission Tomography Study

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