Clinical trial • Phase II • Neurology
PRX005 for Early Alzheimer's disease
Phase II trial of PRX005 for Early Alzheimer's disease. Randomised, placebo (sodium chloride) - dose/schedule not specified-controlled. 391 participants.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Early Alzheimer's disease
- Trial Stage
- Phase II
- Drug Modality
- Monoclonal antibody|Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 08-05-2024
- First CTIS Authorization Date
- 02-09-2024
Trial design
Randomised, placebo (sodium chloride) - dose/schedule not specified-controlled Phase II trial in Spain, Belgium, Sweden.
- Randomised
- Yes
- Comparator
- Placebo (Sodium Chloride) - dose/schedule not specified
- Target Sample Size
- 391
- Trial Duration For Participant
- 532
Eligibility
Recruits 391 isVulnerablePopulationSelected: false; participants are adults aged 50–80. Study partner information and consent forms are provided (L1_SIS and ICF Study Partner documents available)..
- Vulnerable Population
- isVulnerablePopulationSelected: false; participants are adults aged 50–80. Study partner information and consent forms are provided (L1_SIS and ICF Study Partner documents available).
Inclusion criteria
- {"criterion_text":"- Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria."}
- {"criterion_text":"- Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box score of 0.5 and greater at screening and Baseline."}
- {"criterion_text":"- Evidence of AD pathology."}
- {"criterion_text":"- Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory Subtest II (WMS-IV LM II)."}
- {"criterion_text":"- Mini Mental Status Examination (MMSE) score ≥ 20 to 28 (inclusive)."}
Exclusion criteria
- {"criterion_text":"- Any evidence of a condition that may affect cognition other than AD."}
- {"criterion_text":"- Contraindications to PET imaging."}
- {"criterion_text":"- Inability to tolerate or contraindication to magnetic resonance imaging."}
- {"criterion_text":"- Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments."}
- {"criterion_text":"- Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening."}
- {"criterion_text":"- Other protocol-defined Inclusion/Exclusion criteria apply."}
- {"criterion_text":"- Other protocol-defined Inclusion/Exclusion criteria apply."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline at Week 76 in brain tau deposition, as measured by tau positron emission tomography (PET)","definition_or_measurement_approach":"Measured by tau positron emission tomography (PET); change from baseline at Week 76."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline at Week 76 in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score","definition_or_measurement_approach":"Change from baseline at Week 76 measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)."}
- {"endpoint_text":"- Change from baseline at Week 76 in integrated Alzheimer’s Disease Rating Scale (iADRS) score","definition_or_measurement_approach":"Change from baseline at Week 76 measured by the integrated Alzheimer’s Disease Rating Scale (iADRS)."}
- {"endpoint_text":"- Change from baseline at Week 76 in Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS- Cog14) score","definition_or_measurement_approach":"Change from baseline at Week 76 measured by the ADAS-Cog14 cognitive subscale."}
- {"endpoint_text":"- Change from baseline at Week 76 in Mini Mental State Examination (MMSE) score","definition_or_measurement_approach":"Change from baseline at Week 76 measured by the Mini Mental State Examination (MMSE)."}
- {"endpoint_text":"- Change from baseline at Week 76 in Alzheimer’s Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) score","definition_or_measurement_approach":"Change from baseline at Week 76 measured by the ADCS-iADL scale."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 391
- Recruitment Window Months
- 38
- Consent Approach
- Informed consent obtained using subject information sheets and informed consent forms (L1_SIS and ICF Main documents). Separate ICFs available for study partners and pregnant participants. Consent documents available in multiple languages (documents available: English, Dutch, French, and additional language placeholders including Spanish, Polish, Swedish, German/Danish in patient-facing document set). Participants (adults 50–80) provide consent; study partner information/consent documents provided where applicable.
Methods
- Online outreach text and online banners (multiple banner sizes) for public recruitment (documents: K2_Recruitment material Online Outreach Text and many K2 banner files).
- Printed recruitment materials: posters, patient flyers, patient brochures and AD brochures (K2_Recruitment material Poster, Patient Flyer, Patient Brochure).
- Study partner materials and consent discussion aids to support informed consent conversations (K2_Recruitment material Study Partner Brochure; K2_Recruitment material Consent Discussion Aid).
- Site-based recruitment via participating neurology clinics/hospitals (site contact details provided for Belgium, Spain, Sweden).
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 42
Spain
- Earliest CTIS Part Ii Submission Date
- 05-08-2024
- Latest Decision Or Authorization Date
- 09-09-2024
- Processing Time Days
- 35
- Number Of Sites
- 6
- Number Of Participants
- 21
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Neurology
- Principal Investigator Name
- Albert Lladó Plarrumaní
- Principal Investigator Email
- allado@clinic.cat
- Contact Person Name
- Albert Lladó Plarrumaní
- Contact Person Email
- allado@clinic.cat
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Neurology
- Principal Investigator Name
- Juan Fortea Ormaechea
- Principal Investigator Email
- jfortea@santpau.es
- Contact Person Name
- Juan Fortea Ormaechea
- Contact Person Email
- jfortea@santpau.es
- Site Name
- Hospital Universitari De Santa Maria
- Department Name
- Neurology
- Principal Investigator Name
- Gerard Piñol
- Principal Investigator Email
- gpinol@gss.cat
- Contact Person Name
- Gerard Piñol
- Contact Person Email
- gpinol@gss.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Principal Investigator Name
- Maria Pilar Delgado Martinez
- Principal Investigator Email
- pilar.delgado@vhir.org
- Contact Person Name
- Maria Pilar Delgado Martinez
- Contact Person Email
- pilar.delgado@vhir.org
- Site Name
- Hospital Universitari General De Catalunya
- Department Name
- Neurology
- Principal Investigator Name
- Ernest Balaguer Martinez
- Principal Investigator Email
- ebalaguer@quironsalud.es
- Contact Person Name
- Ernest Balaguer Martinez
- Contact Person Email
- ebalaguer@quironsalud.es
- Site Name
- Hospital Del Mar
- Department Name
- Neurology
- Principal Investigator Name
- Albert Puig Pijoan
- Principal Investigator Email
- apuig@psmar.cat
- Contact Person Name
- Albert Puig Pijoan
- Contact Person Email
- apuig@psmar.cat
Belgium
- Earliest CTIS Part Ii Submission Date
- 02-08-2024
- Latest Decision Or Authorization Date
- 02-09-2024
- Processing Time Days
- 31
- Number Of Sites
- 5
- Number Of Participants
- 16
Sites
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Neurology
- Principal Investigator Name
- Frederik Vanhee
- Principal Investigator Email
- frederik.vanhee@azgroeninge.be
- Contact Person Name
- Frederik Vanhee
- Contact Person Email
- frederik.vanhee@azgroeninge.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Neurology
- Principal Investigator Name
- Adrian Ivanoiu
- Principal Investigator Email
- adrian.ivanoiu@uclouvain.be
- Contact Person Name
- Adrian Ivanoiu
- Contact Person Email
- adrian.ivanoiu@uclouvain.be
- Site Name
- Hopital Erasme
- Department Name
- Neurology
- Principal Investigator Name
- Jean-Christophe Bier
- Principal Investigator Email
- jean-christophe.bier@erasme.ulb.ac.be
- Contact Person Name
- Jean-Christophe Bier
- Contact Person Email
- jean-christophe.bier@erasme.ulb.ac.be
- Site Name
- UZ Leuven
- Department Name
- Neurology
- Principal Investigator Name
- Rik Vandenberghe
- Principal Investigator Email
- rik.vandenberghe@uzleuven.be
- Contact Person Name
- Rik Vandenberghe
- Contact Person Email
- rik.vandenberghe@uzleuven.be
- Site Name
- Antwerp University Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Sara Van Mossevelde
- Principal Investigator Email
- sara.vanmossevelde@uza.be
- Contact Person Name
- Sara Van Mossevelde
- Contact Person Email
- sara.vanmossevelde@uza.be
Sweden
- Earliest CTIS Part Ii Submission Date
- 05-08-2024
- Latest Decision Or Authorization Date
- 03-09-2024
- Processing Time Days
- 29
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Minnesmottagningen
- Principal Investigator Name
- Henrik Östlund
- Principal Investigator Email
- henrik.ostlund@skane.se
- Contact Person Name
- Henrik Östlund
- Contact Person Email
- henrik.ostlund@skane.se
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Clario
- Responsibilities
- Customer Care, Site Logistics, Training, Equipment Customisation
- Name
- Yprime LLC
- Responsibilities
- IVRS – treatment randomisation, Subject number assignment, treatment/arm assignment, drug (re)supplies assignment
- Name
- Medidata Solutions Inc.
- Name
- Fortrea Inc.
- Name
- Signant Health Global LLC
- Responsibilities
- ECOA
Third parties
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Clinical chemistry, Clinical haematology, Sample Management, Kit Building, Sample storage and shipments to speciality labs for analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Clario","duties_or_roles":"Customer Care, Site Logistics, Training, Equipment Customisation","organisation_type":"Health care"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Services Pvt. Ltd.","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"SME"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"ECOA","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"C2n Diagnostics LLC","duties_or_roles":"Phosphorylated-Tau 217 (pTau 217), Amyloid beta-40/42 and Amyloid Probability Score 2 testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Routine clinical pathology testing, Clinical chemistry, Clinical haematology, Clinical microbiology, other APH","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Routine clinical pathology testing, clinical chemistry, clinical hematology, clinical microbiology","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"IVRS – treatment randomisation, Subject number assignment, treatment/arm assignment, drug (re)supplies assignment","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- PRX005
- Active Substance
- PRX005
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Investigational Product Name
- Florquinitau F-18
- Active Substance
- FLORQUINITAU (18F)
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Authorised
- Investigational Product Name
- Sodium Chloride
- Modality
- Other
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