Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000042549
Ethics application status
Approved
Date submitted
18/12/2014
Date registered
21/01/2015
Date last updated
22/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Detection of Individuals with Preclinical, Prodromal and Mild Alzheimer's Disease for Therapeutic Trials.
Scientific title
Detection of Individuals with Preclinical, Prodromal and Mild Alzheimer's Disease optimizing the use of cognitive and blood biomarker findings to increase the rate of amyloid scan positive subjects using Amyloid and Fluorodeoxyglucose Positron Emission Tomography (FDG PET) imaging for Therapeutic trials.
Secondary ID [1] 285875 0
NIL
Universal Trial Number (UTN)
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preclinical Alzheimer's Disease 293794 0
Prodromal Alzheimer's Disease 293883 0
Mild Alzheimer's Disease 293884 0
Condition category
Condition code
Neurological 294097 294097 0 0
Alzheimer's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive assessment will be performed at visits one and four lasting approximately one hour.
Blood biomarker sampling will occur at visit 4.
The Amyloid PET scan will be done at visit two and involves intravenous injection of 200 +/-10%MBq of (18F)Nav4694. A 20-minute scan will be acquired starting at 50 minutes post injection. Where MRI Brain scan results with a 3D sequence from within the past six months are not available, an MRI will be done at visit 2 or visit 3. An FDG PET scan will be done at visit three using an intravenous injection of 185 +/-10% of (18F)FDG. A 15-minute scan will be acquired starting at 30 minutes post injection.
Intervention code [1] 290856 0
Early detection / Screening
Intervention code [2] 290926 0
Diagnosis / Prognosis
Comparator / control treatment
Amyloid imaging will be compared to MRI and FDG PET imaging.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293888 0
Early detection of Alzheimer's Disease through use of Amyloid and FDG PET scans, and blood biomarkers, in conjunction with other standard imaging, neuropsychological and medical assessments.
Timepoint [1] 293888 0
Following completion of imaging, cognitive assessment and blood biomarker testing.
Secondary outcome [1] 312095 0
Develop a register of subjects with a diagnosis of Preclinical, Prodromal or Mild Alzheimer's Disease who wish to be contacted when therapeutics trials become available.
Timepoint [1] 312095 0
Following completion of investigative procedures and discussion with the subject and their usual medical practitioner, therapeutic trials will be offered when they become available.

Eligibility
Key inclusion criteria
Mild cognitive impairment or mild Alzheimer's Disease.
> 6years of education.
Adequate English and visual and auditory acuity for psychometric testing.
Able to undergo MRI imaging.
MMSE 20 and above.
An interest in research participation.
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other neurodegenerative disorders, severe mental illnesses. History of cancer within the last 5 years (excluding skin or insitu prostate cancer).
Drug and alcohol abuse.
MRI contraindications.

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)
Subjects are enrolled following Specialist confirmation of Preclinical, Prodromal or Mild Alzheimer's disease.
They attend a screening visit for Study discussion and Informed Consent. They are then assessed according to the inclusion and exclusion criteria and are enrolled in the study if eligible.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nonrandomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
17/12/2014
Actual
17/12/2014
Date of last participant enrolment
Anticipated
1/12/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
300
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3290 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 9073 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 290458 0
Government body
Name [1] 290458 0
NHMRC Grant APP1071430
Country [1] 290458 0
Australia
Funding source category [2] 290536 0
Commercial sector/Industry
Name [2] 290536 0
Investigator Sponsored Study through a Clinical Trial Research Agreement with AstraZeneca Pharmaceuticals LP.
Country [2] 290536 0
United States of America
Primary sponsor type
Individual
Name
Professor Chris Rowe
Address
Austin Health
145 Studley Road
Heidelberg, Victoria
Australia 3084
Country
Australia
Secondary sponsor category [1] 289160 0
None
Name [1] 289160 0
Address [1] 289160 0
Country [1] 289160 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292131 0
Austin Health Human Research Ethics
Ethics committee address [1] 292131 0
Ethics committee country [1] 292131 0
Australia
Date submitted for ethics approval [1] 292131 0
17/07/2014
Approval date [1] 292131 0
12/09/2014
Ethics approval number [1] 292131 0
HREC/14/Austin/325

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53642 0
Prof Christopher Rowe
Address 53642 0
Austin Health
145 Studley Rd
Heidelberg, Victoria
Australia 3084
Country 53642 0
Australia
Phone 53642 0
+61 03 9496 5000
Fax 53642 0
Email 53642 0
chris.rowe@austin.org.au
Contact person for public queries
Name 53643 0
Cheryl Donohue
Address 53643 0
The Florey Institute of Neuroscience and Mental Health
155 Oak St
Parkville, Victoria
Australia 3052
Country 53643 0
Australia
Phone 53643 0
+61 03 9389 2938
Fax 53643 0
+61 03 9387 5061
Email 53643 0
cheryl.donohue@florey.edu.au
Contact person for scientific queries
Name 53644 0
Chris Rowe
Address 53644 0
Austin Health
145 Studley Rd
Heidelberg, Victoria
Australia 3084
Country 53644 0
Australia
Phone 53644 0
+61 03 9496 5000
Fax 53644 0
Email 53644 0
chris.rowe@austin.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.