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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01890343 |
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Date of registration:
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27/06/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.
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Scientific title:
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A Study Evaluating the Imaging Characteristics of Florbetapir 18F (18F-AV-45) in Patients With Frontotemporal Dementia Compared to Patients With Alzheimer's Disease and Normal Controls. |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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34 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01890343 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Chief Medical Officer |
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Address:
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Telephone:
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Email:
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Affiliation:
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Avid Radiopharmaceuticals |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
AD:
- Male or female >= 50 years of age
- Meet National Institute of Neurological and Communicative Disorders and Stroke
(NINCDS) criteria for probable AD and have a Mini Mental State Examination (MMSE)
score at screening between 10 and 24 inclusive
- Have a caregiver who can report on their mental status and activities of daily living
(ADL)
- Give informed consent or have a caregiver give consent with subject assent.
FTD:
- Male or female >= 45 years of age
- Meet consensus criteria for FTD and have mild to moderate disease severity. Have a
caregiver who can report on their mental status and ADL
- Give informed consent or have a caregiver give consent with subject assent.
CN:
- Male or female >= 45 years of age
- Have and MMSE >= 29
- Give informed consent
Exclusion Criteria:
- Have a history or a current clinically significant neurologic disease (other than AD
or FTD, as applicable), a diagnosis of other dementing/neurodegenerative disease, or a
diagnosis of mixed dementia
- Evidence from MRI or other biomarkers that suggests an etiology of dementia other than
AD or FTD, as applicable or in the case of CN subjects evidence indicating the
presence of AD, FTD or other types of neurologic pathology
- Have current clinically significant cardiovascular disease, screening ECG
abnormalities, psychiatric disease, endocrine or metabolic disease, pulmonary, renal
or hepatic impairment, cancer or infectious disease
- Have a recent history of alcohol or substance abuse or dependence
- Women of childbearing potential who are not permanently surgically sterile, or are not
refraining from sexual activity while not using adequate contraception.
- Require medications with a narrow therapeutic window, are receiving any
investigational medications, or have participated in a trial with investigational
medications within the last 30 days
- Have ever participated in a study with an amyloid targeting agent
- Have had a radiopharmaceutical imaging or treatment procedure within 7 days of the
imaging, other than as defined in the protocol
Age minimum:
45 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Frontotemporal Dementia
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Alzheimer's Disease
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Intervention(s)
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Drug: 18F-FDG
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Drug: florbetapir 18F
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Primary Outcome(s)
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Qualitative Amyloid Image Assessment
[Time Frame: 50-60 min after injection]
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Quantitative Amyloid Image Assessment
[Time Frame: 50-60 minutes after injection]
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Secondary ID(s)
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18F-AV-45-010
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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