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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mutation carrier | Active Comparator |
| |
| mutation non-carrier | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Florbetaben | Radiation | single dose of Florbetaben followed by PET scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events of a single dose of FBB followed by PET scan in individuals at risk of genetic Alzheimer?s disease. | At baseline, when FBB-PET is performed. | |
| Proportion of FAD mutation carriers that present positive uptake after FBB-PET through visual examination | At baseline, when FBB-PET is performed. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of FAD mutation carriers presenting standardized uptake value ratios (SUVRs) of FBB-PET higher than 1,4. | baseline | |
| Areas of significant difference (p<0,05) in regional SUVR between FAD mutation carriers and non-carriers. | baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raquel Sánchez | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital ClĂnic de Barcelona | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C527756 | 4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene |
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| Earliest age of positive FBB-PET in FAD mutation carriers. | baseline |
| Individual cortical areas with positive amyloid deposition at visual or semi-quantitative assessment | baseline |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |