Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03901105




Registration number
NCT03901105
Ethics application status
Date submitted
28/03/2019
Date registered
3/04/2019
Date last updated
28/08/2020

Titles & IDs
Public title
Evaluation of Flortaucipir PET Signal and Cognitive Change in Early Alzheimer's Disease
Scientific title
Evaluation of the Relationship Between Baseline Flortaucipir PET Signal and Cognitive Change in Subjects With Early Alzheimer's Disease Participating in the I8D-MC-AZES Protocol Addendum D5010C00009 (2.1) (Tau Imaging)
Secondary ID [1] 0 0
18F-AV-1451-PX01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - flortaucipir F18
Treatment: Surgery - Brain PET Scan

Experimental: Flortaucipir PET Scan - No study drug will be administered. Scans previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) will be read by independent, blinded readers.


Treatment: Drugs: flortaucipir F18
No study drug will be administered. Scans previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) at baseline will be read by independent, blinded readers. IV injection, 240 megabecquerel (MBq) (6.5 mCi), single dose in AZES

Treatment: Surgery: Brain PET Scan
positron emission tomography (PET) scan of the brain
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Risk Ratio for AD Symptom Progression on CDR-SB
Timepoint [1] 0 0
Within 18 months of scan
Secondary outcome [1] 0 0
Risk Ratio for AD Symptom Progression on Various Clinical Measures
Timepoint [1] 0 0
Within 18 months of scan
Secondary outcome [2] 0 0
Mean Change in Cognitive/Functional Assessments
Timepoint [2] 0 0
baseline and 18 months
Secondary outcome [3] 0 0
Inter-Reader Reliability of Reader Interpretation of Flortaucipir F 18 PET Imaging
Timepoint [3] 0 0
baseline scan

Eligibility
Key inclusion criteria
Scan Reader Criteria (5 total readers):

* Board-certified in radiology or nuclear medicine
* Professional experience interpreting PET scans

Scan Criteria (205 total scans):

* Former enrollment in AZES Study
* Flortaucipir scan at baseline
* clinical dementia rating - sum of boxes (CDR-SB) assessment at 18 months

Scan Study Population (AZES Study):

* 55 to 85 years
* MCI due to AD or probable AD by National Institute on Aging-Alzheimer's Association criteria (Albert 2011
* mini-mental status exam (MMSE) of 20 to 30 inclusive
* CDR global score of 0.5 (MCI), or 0.5 or 1 (AD) with a memory box score = 0.5, and a score of =85 on the Delayed Memory Index of the Repeatable Battery for the Assessment of Neuropsychological Status.
* Amyloid positive status confirmed by florbetapir PET or lumbar puncture
Minimum age
55 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
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
28/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/04/2019
Sample size
Target
Accrual to date
Final
205
Recruitment in Australia
Recruitment state(s)
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 will evaluate whether visual interpretation of flortaucipir-PET (positron emission tomography) scans, examining patterns of tracer uptake at baseline, can predict the rate of clinically-meaningful cognitive decline due to AD after 18 months. All scans are acquired from cohorts of a previously completed study, I8D-MC-AZES (NCT02245737, lanabecestat, Eli Lilly and Company sponsor).
Trial website
https://clinicaltrials.gov/study/NCT03901105
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Avid Radiopharmaceuticals
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/study/NCT03901105