Phase 1
Completed N=45
Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients
Alzheimer's Disease · Amyloid Beta-Protein
Source: ClinicalTrials.gov NCT01138111 ↗
Enrolled (actual)
45
Serious AEs
1.6%
Results posted
Jun 2014
Primary outcomePrimary: Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake — 1.430; 1.726; 1.442; 1.738 SUVR — p=0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake |
1.430; 1.726; 1.442; 1.738; 1.439; 1.796 | 0.0001 sig |
| SECONDARY 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 |
17; 2; 15; 2; 12; 1 | — |
| SECONDARY 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 |
15; 2; 16; 0; 14; 0 | — |
| SECONDARY 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 |
89.47; 100.00; 100.00; 94.12; 100.00; 85.71 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT01138111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.