Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients

NCT01138111 | Completed Phase 1 Results

• 1 other identifier: 312043
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Amyloid Beta-Protein

Keywords

Florbetaben; Amyloid beta-protein; MCI; Alzheimer's disease

Outcome Measures

Primary Outcomes (1)

• Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake

  Mean SUVRs were calculated for subjects who did and did not progress to Alzheimer's Disease (AD) during the study for each PET scan time point (baseline, 12 and 24 months)

  1 scanning period post injection to be evaluated at baseline, 12 months and 24 months

Secondary Outcomes (3)

• 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

  1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months

• 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

  2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months

• 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

  2 scanning periods post injection to be evaluated at baseline

Study Arms (1)

Arm 1

EXPERIMENTAL

Drug: Florbetaben (BAY94-9172)

Interventions

Florbetaben (BAY94-9172) DRUG

single 300 megabecquerel (MBq) intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months

Arm 1

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Life Molecular Imaging SA: lead

Study Sites (1)

Unknown Facility

Heidelberg, Victoria, 3084, Australia

Location

Related Publications (2)

• 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.

  PMID: 33773598 DERIVED

• 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.

  PMID: 24970906 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Plaque, Amyloid

Interventions

4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Juergen Hirschfeld, Senior Director Regulatory Affairs
• Organization: Piramal Imaging

juergen.hirschfeld@piramal.com

+49 30 461 1246 15

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: June 7, 2010
• Study Start: June 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 25, 2014
• Results First Posted: June 25, 2014

Record last verified: 2014-05

Locations

AU (1)