Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers

NCT ID: NCT00750282

Last Updated: 2014-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-11-30

Brief Summary

The aim of this study is to evaluate the efficacy, safety of a single dose of BAY 94-9172 (ZK 6013443) as an investigational medicinal product (IMP) in detecting cerebral protein-plaque (amyloid beta) with positron emission tomography (PET). IMP binds to amyloidal beta protein accumulating in brain tissue already from early stages of Alzheimer's disease (AD). IMP is therefore a potential tracer to be used for detecting amyloid plaques. For each subject it is required to visit the study centre during the screening phase, on the PET imaging day and for 1 follow-up visit on the next day. A telephone call for safety follow-up will be performed 7 days after IMP administration. During the screening phase the subject's medical, neurological and surgical history, specific laboratory tests related to AD, MRI of the brain and certain neuro-psychiatric tests will be performed. Clinical safety measures (physical examinations, vital signs, electrocardiogram (ECG) and laboratory tests) will be performed on the PET imaging day before IMP injection and monitored during and after two PET imaging sessions. Clinical safety measures will be performed again on the follow-up visit next day. The results of PET imaging with IMP will be compared between probable AD patients and healthy volunteers (HV). The clinical diagnosis is based on international validated and accepted criteria and established after comprehensive clinical and neuro-psychiatric examinations

Conditions

Alzheimer Disease; Amyloid Beta-Protein

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Florbetaben (BAY94-9172)

Group Type: EXPERIMENTAL

Florbetaben (BAY94-9172)

Intervention Type: DRUG

Healthy volunteers and patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions

Interventions

Florbetaben (BAY94-9172)

Healthy volunteers and patients with probable Alzheimer's disease receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Each subject / Healthy volunteer (HV) who meets the following criteria will be eligible for enrollment into the study:

• Is a man or woman and is > 55 of age, whereby females must be without childbearing potential (confirmed by either: age >/= 60; or history of hysterectomy, or last spontaneous bleeding at least 2 years prior to the study start)
• Has at least 6 years of education
• Is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and to comply with study procedures
• Possesses a general health that permits adequate compliance with all study procedures
• The subject, or the subject and caregiver (for probable AD patients) will be compliant and have a high probability of completing the study
• Informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable AD patients)

• Has no evidence of cognitive impairment
• Has MRI brain scan that has been judged as "normal" (age- appropriate)

• Presents with positive assessment for dementia of Alzheimer's type
• Does not fulfill the criteria Dementia with Lewy Bodies (DLB) or Vascular Dementia (VaD)
• MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease
• Has a caregiver that is willing and able to attend all study visits and perform the psychometric tests requiring the presence of a caregiver

Exclusion Criteria

• Has any contraindication to MRI examination scan
• Is scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following IMP application
• Is allergic to the IMP or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients / volunteers with allergic asthma)
• is critically ill and/or medically unstable and whose clinical course during the observation period is unpredictable
• Has a history of exposure to any radiation >15 milli Sieverts (mSv)/year (e.g. occupational or radiation therapy)
• Is receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
• Has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening, and/or any radiopharmaceutical
• Has a brain tumor or other intracranial lesion, a disturbance of cerebro-spinal fluid (CSF) circulation (e.g., normal pressure hydrocephalus) and/or a history of head trauma or brain surgery
• Has an inflammatory or infectious central nervous system (CNS) disease, e.g. multiple sclerosis, HIV, syphilis, or Creutzfeldt-Jacob disease
• Has a history, physical, laboratory or imaging findings indicative of a neurological or psychiatric illness
• Has another disease that can cause disturbance of brain function (e.g. vitamin B12 or folic acid deficiency, disturbed thyroid function)
• Has a history of alcohol or drug abuse
• Has history of severe persistent depression

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Life Molecular Imaging SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Sun City, Arizona, United States

Stanford, California, United States

New Haven, Connecticut, United States

New York, New York, United States

New York, New York, United States

The Bronx, New York, United States

Providence, Rhode Island, United States

Westmead, New South Wales, Australia

Adelaide, South Australia, Australia

Heidelberg, Victoria, Australia

Erlangen, Bavaria, Germany

München, Bavaria, Germany

München, Bavaria, Germany

Essen, North Rhine-Westphalia, Germany

Jülich, North Rhine-Westphalia, Germany

Münster, North Rhine-Westphalia, Germany

Dresden, Saxony, Germany

Leipzig, Saxony, Germany

Berlin, State of Berlin, Germany

Kobe, Hyōgo, Japan

Kobe, Hyōgo, Japan

Bunkyo-ku, Tokyo, Japan

Zurich, Canton of Zurich, Switzerland

Countries

United States; Australia; Germany; Japan; Switzerland

References

Barthel H, Gertz HJ, Dresel S, Peters O, Bartenstein P, Buerger K, Hiemeyer F, Wittemer-Rump SM, Seibyl J, Reininger C, Sabri O; Florbetaben Study Group. Cerebral amyloid-beta PET with florbetaben (18F) in patients with Alzheimer's disease and healthy controls: a multicentre phase 2 diagnostic study. Lancet Neurol. 2011 May;10(5):424-35. doi: 10.1016/S1474-4422(11)70077-1. Epub 2011 Apr 8.

Reference Type: RESULT

PMID: 21481640 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33773598 (View on PubMed)

Other Identifiers

2007-002256-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

311741

Identifier Type: OTHER

Identifier Source: secondary_id

311741

Identifier Type: -

Identifier Source: org_study_id