Clinical trial NCT01138111: Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients
Official title: ß-amyloid Imaging With BAY94-9172 Positron Emission Tomography for Early Detection of Alzheimer's Disease in Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Amyloid Beta-Protein
Keywords: Florbetaben
Amyloid beta-protein
MCI
Alzheimer's disease
Lead sponsor: Life Molecular Imaging SA
Sponsor class: INDUSTRY
First posted: 2010-06-07
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake
timeFrame: 1 scanning period post injection to be evaluated at baseline, 12 months and 24 months
Secondary outcomes:
measure: 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
timeFrame: 1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months
measure: 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
timeFrame: 2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months
measure: 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
timeFrame: 2 scanning periods post injection to be evaluated at baseline
Other outcomes:
Locations:
city: Heidelberg
country: Australia
state: Victoria
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Bullich S, Roe-Vellve N, Marquie M, Landau SM, Barthel H, Villemagne VL, Sanabria A, Tartari JP, Sotolongo-Grau O, Dore V, Koglin N, Muller A, Perrotin A, Jovalekic A, De Santi S, Tarraga L, Stephens AW, Rowe CC, Sabri O, Seibyl JP, Boada M. Early detection of amyloid load using 18F-florbetaben PET. Alzheimers Res Ther. 2021 Mar 27;13(1):67. doi: 10.1186/s13195-021-00807-6.
citation: Ong KT, Villemagne VL, Bahar-Fuchs A, Lamb F, Langdon N, Catafau AM, Stephens AW, Seibyl J, Dinkelborg LM, Reininger CB, Putz B, Rohde B, Masters CL, Rowe CC. Abeta imaging with 18F-florbetaben in prodromal Alzheimer's disease: a prospective outcome study. J Neurol Neurosurg Psychiatry. 2015 Apr;86(4):431-6. doi: 10.1136/jnnp-2014-308094. Epub 2014 Jun 26.