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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/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
N/A
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
The aim of the study is to investigate whether Florbetaben (BAY94-9172)positron emission
tomography (PET) is able to distinguish between subjects with mild cognitive impairment (MCI)
progressing to Alzheimer's disease (AD) from those with MCI not progressing to AD.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01138111
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