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/NCT01138111




Registration number
NCT01138111
Ethics application status
Date submitted
1/04/2010
Date registered
7/06/2010
Date last updated
25/06/2014

Titles & IDs
Public title
Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients
Scientific title
ß-amyloid Imaging With BAY94-9172 Positron Emission Tomography for Early Detection of Alzheimer's Disease in Patients With Mild Cognitive Impairment
Secondary ID [1] 0 0
312043
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Amyloid Beta-Protein 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Florbetaben (BAY94-9172)

Experimental: Arm 1 -


Treatment: Drugs: Florbetaben (BAY94-9172)
single 300 megabecquerel (MBq) intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake
Timepoint [1] 0 0
1 scanning period post injection to be evaluated at baseline, 12 months and 24 months
Secondary outcome [1] 0 0
Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4
Timepoint [1] 0 0
1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months
Secondary outcome [2] 0 0
Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress
Timepoint [2] 0 0
2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months
Secondary outcome [3] 0 0
Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress
Timepoint [3] 0 0
2 scanning periods post injection to be evaluated at baseline

Eligibility
Key inclusion criteria
* Presence of MCI defined as abnormal cognition on objective testing in the absence of dementia or significant functional loss.
* Absence of systemic or other neurological disease that may contribute to cognitive impairment or prevent follow-up over two years.
* Able to give written informed consent.
* Age >/= 60 years of age
* >/= 7 years of education
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Mini mental state examination (MMSE) score < 24 at baseline
* Clinical dementia rating (CDR) score > 0.5 at baseline
* Patients who receive regular medication of drugs which may adversely impact cognition (e.g. tricyclic antidepressants, antipsychotics and/or large doses of hypnotics or anxiolytics)
* Existing or history of cancer
* History of severe head trauma, brain surgery or intracranial hematoma with permanent brain lesion
* Lifetime history of major affective disorder, schizophrenia, or schizo-affective disorder
* Contraindications to MRI (Magnetic resonance imaging)
* Relevant history, physical or imaging findings of neurological disease other than MCI and mild depression
* History of severe anaphylactic reaction or high risk of allergic reaction to drugs
* Patient has received another investigational drug in the preceding 14 days

Study design
Purpose of the study
Diagnosis
Allocation to intervention
NA
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 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
1/06/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2011
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Life Molecular Imaging SA
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
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

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

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01138111