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EUCTR2015-003034-27

DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY AND SAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODROMAL- TO-MILD ALZHEIMER’S DISEASE

Datenbasis: WHO (Import vom 05.08.2018)
Geändert: 05.08.2018
Krankheitskategorie:

Health conditions (Datenquelle: WHO)

Alzheimer’s Disease (AD)
MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852

Interventions (Datenquelle: WHO)


Product Name: crenezumab
Product Code: Ro 549-0245/F05
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: crenezumab
CAS Number: 1095207-05-8
Current Sponsor code: RO5490245
Other descriptive name: Crenezumab, Anti Abeta, MABT5102A
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-
Pharmaceutical form of the placebo: Concentrate for solution for infusion
Route of administration of the placebo: Intravenous use

Inclusion/Exclusion Criteria (Datenquelle: WHO)

Inclusion criteria:
• Must meet clinical criteria for MCI due to AD or mild AD (per NIAAA criteria) and must have:
• A Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.0
• Objective evidence of cognitive impairment at screening
• An MMSE score =22
• Must have evidence of AD pathology confirmed by positive amyloid assessment (by PET scan or CSF measurement)
• Must consent to genotyping for apolipoprotein E (ApoE)
• If using drugs to treat symptoms related to AD, doses must be stable for at least 3 months prior to screening
• Must have a reliable study partner or caregiver
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion criteria:
• Any medical or neurological condition (other than Alzheimer's Disease) that might result in cognitive impairment.
• Have had a stroke resulting in clinical symptoms within 2 years or Transient Ischemic Attack (TIA) within 6 months
• History of serious psychiatric illness or untreated major depressive disorder
• History of unstable angina, myocardial infarction, advanced chronic heart failure within 2 years prior to screening
• Have human immunodeficiency virus (HIV) infection
• Relevant brain hemorrhage or cerebrovascular abnormalities
• Any contraindications to brain magnetic resonance imaging (MRI) scans
• Alcohol or substance abuse in past 2 years
• Anti-coagulation medications within 3 months of screening – antiplatelet therapies including clopidogrel are permitted.

Weitere Angaben zur Studie im WHO-Primärregister

https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003034-27

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2015-003034-27

Weitere Informationen zur Studie

Registrationsdatum der Studie

07.07.2016

Einschluss der ersten teilnehmenden Person

05.07.2016

Rekrutierungsstatus

Authorised-recruitment may be ongoing or finished

Wissenschaftlicher Titel (Datenquelle: WHO)

A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE- BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY ANDSAFETY STUDY OF CRENEZUMAB IN PATIENTS WITH PRODOMAL-TO-MILD ALZHEIMER’S DISEASE

Studientyp (Datenquelle: WHO)

Interventional clinical trial of medicinal product

Design der Studie (Datenquelle: WHO)

Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: yes
Other specify the comparator: PET Ligand (florbetapir F18)
Number of treatment arms in the trial: 2

Phase (Datenquelle: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primäre Endpunkte (Datenquelle: WHO)

Main Objective: Efficacy:evaluate crenezumab 60mg/kg compared with placebo when admin. by IVinfusion q4w over 100wks as measured by the CDR-SB(final outcome assessment at Wk 105,4 wks after final dose)Change from baseline on CDR-sum of boxes
Safety:evaluate safety of crenezumab compared with placebo in patients with prodromal to mild AD on the basis of following endpoints
•Nature,frequency,severity and timing of adverse events and serious adverse events
•Physical and neurologic examinations,vital signs,blood tests,ECGs,Columbia Suicide Severity Rating Scale,Non-serious adverse events of special interest,specific.pneumonia
•Adverse events,as assessed by magnetic resonance imaging:amyloid related imaging abnormalities edema/effusion and amyloid related imaging abnormalities hemosiderin deposition
•Immunogenic potential of crenezumab through measurement of antibodies directed against crenezumab and other components of the drug product,assessment of their relationship with other outcome measures;Secondary Objective: Efficacy: secondary efficacy objectives for this study are to evaluate the benefits of crenezumab versus placebo administered to patients by IV
infusion Q4W over 100 weeks through assessment of the following endpoints
Change from baseline to Week 105 on:
•Cognition, as assessed by the ADAS-Cog (subscale) 13 (ADAS Cog 13) and 11 (ADAS-Cog-11)
•severity of dementia, assessed using the CDR-Global Score (CDR GS) and MMSE
•function, assessed using the ADCS-ADL instrumental subscale (ADCSiADL) and ADCS-ADL total score
•neuropsychological symptoms, assessed using the Neuropsychiatric Inventory Questionnaire (NPI-Q) total score
•Effect of crenezumab on health-related quality of life (QoL), assessed using the Quality of Life-Alzheimer's Disease scale, caregiver burden, assessed using the Zarit Caregiver Interview for Alzheimer's Disease scale and on health outcomes in patient and caregiver as measured by EQ-5D
• Measure of dependence derived from the ADCS-ADL score;Primary end point(s): To evaluate crenezumab 60 mg/kg compared with placebo when administered by IV infusion q4w over 100 weeks as measured by the following primary endpoint (final outcome assessment at Week 105, 4 weeks after the final dose): Global outcomes, as assessed by the CDR SB

Sekundäre Endpunkte (Datenquelle: WHO)

Secondary end point(s): To evaluate the benefits of crenezumab versus placebo administered to patients by IV infusion q4w over 100 weeks through assessment of the
following endpoints: Effect on cognition, as assessed by the ADAS-Cog (subscale) 13 (ADAS Cog 13) and 11 (ADAS-Cog-11); effect on dementia severity as assessed by CDR Global Score (CDR-GS) and MMSE; effect on function as assessed by the ADCS-ADL total score and the ADCSinstrumental ADL subscore; effect on a measure of dependence derived from the ADCS-ADL score; effect on neuropsychological symptoms assessed by Neuropsychiatric Inventory Questionnaire (NPI-Q)

Kontakt für Auskünfte (Datenquelle: WHO)

F. Hoffmann-La Roche Ltd.

Studiendurchführungsorte

Durchführungsländer (Datenquelle: WHO)

Australia, Austria, Belgium, Bulgaria, Canada, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Italy, Japan, Korea, Lithuania, Mexico, Poland, Portugal, Republic of, Russian Federation, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Kingdom, United States

Kontakt für weitere Auskünfte zur Studie

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Trial Information Support Line-TISL
Grenzacherstrasse 124
F.Hoffmann-La Roche Ltd.
+4161 688 1111
global.rochegenentechtrials@roche.com

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Trial Information Support Line-TISL
Grenzacherstrasse 124
F.Hoffmann-La Roche Ltd.
+4161 688 1111
global.rochegenentechtrials@roche.com

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

F. Hoffman-La Roche Ltd.

Weitere Studienidentifikationsnummern

Secondary ID (Datenquelle: WHO)

BN29552