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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02120664




Registration number
NCT02120664
Ethics application status
Date submitted
17/04/2014
Date registered
23/04/2014
Date last updated
9/03/2017

Titles & IDs
Public title
Florbetapir Calibration to the Centiloid Scale
Scientific title
A Multicenter, Multicountry Study to Calibrate Florbetapir (18F) PET Imaging Data to the Centiloid Scale Based on 11C-PiB
Secondary ID [1] 0 0
18F-AV-45-A22
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Florbetapir (18F)
Treatment: Drugs - 11C-PiB

Experimental: Amyloid Negative Subjects - Approximately 10 cognitively normal young subjects will receive a single i.v. bolus injection of approximately 370 megabecquerel (MBq) (10 millicurie [mCi]) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.

Experimental: Amyloid Positive Subjects - Approximately 25 subjects with a range of amyloid density comprised of subjects clinically diagnosed with Alzheimer's Disease (AD) and subjects at risk for elevated amyloid density will receive a single i.v. bolus injection of approximately 370 MBq (10 mCi) florbetapir (18F) and a single i.v. bolus injection of approximately 555 MBq (15 mCi) 11C-PiB.


Treatment: Drugs: Florbetapir (18F)


Treatment: Drugs: 11C-PiB
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Florbetapir SUVr Conversion to Centiloid Units
Timepoint [1] 0 0
up to 70 minutes post injection
Secondary outcome [1] 0 0
Correlation of Florbetapir (18F) Centiloid and 11C-PiB Centiloid
Timepoint [1] 0 0
up to 70 minutes post injection
Secondary outcome [2] 0 0
Variability of PET Images in Young Healthy Control Subjects.
Timepoint [2] 0 0
up to 70 minutes post injection

Eligibility
Key inclusion criteria
- Cognitively Normal Subjects

- Males or females = 21 and = 45 years of age

- Mini-mental state examination (MMSE) = 29

- Clinically Diagnosed AD Subject

- Males or females = 50 years of age

- Meet clinical criteria for dementia due to probable AD

- MMSE = 16 and = 26

- Possible AD Subject

- Males or females = 50 years of age

- Meet clinical criteria for dementia due to possible AD

- MMSE = 16 and = 26

- MCI Subject

- Males or females = 60 years of age with cognitive impairment (not dementia)

- MMSE >24 and <29

- At Risk Elderly Subject

- Cognitively normal males or females that are known ApoE4 carriers and = 75 years
of age

- MMSE = 27
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Have had or currently have a diagnosis of neurodegenerative disorders other than AD

- Have a current serious or unstable illness that could interfere with completion of the
study

- Subject has a known brain lesion, pathology or traumatic brain injury

- Have received or participated in a trial with investigational medications in the past
30 days

- Have had a radiopharmaceutical imaging or treatment procedure within 7 days of study
imaging session

- Females of childbearing potential who are not surgically sterile, not refraining from
sexual activity or not using reliable methods of contraception

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Pennsylvania

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Avid Radiopharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to demonstrate the conversion of florbetapir (18F) Positron Emission
Tomography (PET) Standard Uptake Value ratio (SUVr) to Centiloid units.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02120664
Trial related presentations / publications
Klunk WE, Koeppe RA, Price JC, Benzinger TL, Devous MD Sr, Jagust WJ, Johnson KA, Mathis CA, Minhas D, Pontecorvo MJ, Rowe CC, Skovronsky DM, Mintun MA. The Centiloid Project: standardizing quantitative amyloid plaque estimation by PET. Alzheimers Dement. 2015 Jan;11(1):1-15.e1-4. doi: 10.1016/j.jalz.2014.07.003. Epub 2014 Oct 28.
Public notes

Contacts
Principal investigator
Name 0 0
Chief Medical Officer
Address 0 0
Avid Radiopharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02120664