Alzheimer DiseaseNCT02362880
Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease 18F-Florbetaben Positron Emission Tomography Study
A study testing Florbetaben in people with Alzheimer Disease, run by Judit Pich Martínez at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Florbetaben
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2015to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease: 18F-Florbetaben Positron Emission Tomography Study
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.
- Conditions
- Alzheimer Disease
- Being tested
- Florbetaben
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlorbetabenRadiation
single dose of Florbetaben followed by PET scan
| Study group | Role | What they receive |
|---|---|---|
| mutation carrier | Active comparator | Not described Receives: Radiation: Florbetaben |
| mutation non-carrier | Sham comparator | Not described Receives: Radiation: Florbetaben |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals at risk of genetic Alzheimer?s disease.
Measured: At baseline, when FBB-PET is performed.
Proportion of FAD mutation carriers that present positive uptake after FBB-PET through visual examination
Measured: At baseline, when FBB-PET is performed.
Secondary outcomes (4)
Proportion of FAD mutation carriers presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.
Measured: baseline
Areas of significant difference (p<0,05) in regional SUVR between FAD mutation carriers and non-carriers.
Measured: baseline
Earliest age of positive FBB-PET in FAD mutation carriers.
Measured: baseline
Individual cortical areas with positive amyloid deposition at visual or semi-quantitative assessment
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2019
- Study completionJan 2019
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Judit Pich Martínez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Judit Pich Martínez, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Raquel Sánchez, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02362880
- Sponsor's protocol ID
- FBB-FAD-2014
- Status last verified
- Apr 2021
- First submitted
- 9 Feb 2015
- Last updated
- 14 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Genetic Alzheimer's Disease Mutation Carriers in Preclinical Stages of the Disease: 18F-Florbetaben Positron Emission Tomography Study
- ClinicalTrials.gov ID
- NCT02362880
- Acronym / sponsor ID
- FBB-FAD-2014
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Judit Pich MartínezUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 13 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mutation carrier | Active comparator | Radiation: Florbetaben |
| mutation non-carrier | Sham comparator | Radiation: Florbetaben |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Florbetabensingle dose of Florbetaben followed by PET scan | Radiation | mutation carrier, mutation non-carrier |
Primary outcome
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.
Proportion of FAD mutation carriers that present positive uptake after FBB-PET through visual examination
Time frame: At baseline, when FBB-PET is performed.
4 secondary outcomes
Proportion of FAD mutation carriers presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4.
Time frame: baseline
Areas of significant difference (p<0,05) in regional SUVR between FAD mutation carriers and non-carriers.
Time frame: baseline
Earliest age of positive FBB-PET in FAD mutation carriers.
Time frame: baseline
Individual cortical areas with positive amyloid deposition at visual or semi-quantitative assessment
Time frame: baseline
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel Sánchez principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Florbetaben in people with Alzheimer Disease, run by Judit Pich Martínez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.