Clinical trial • Phase III • Neurology
DONANEMAB for Alzheimer's disease | Dementia
Phase III trial of DONANEMAB for Alzheimer's disease | Dementia.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Alzheimer's disease | Dementia
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody | Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 09-07-2025
- First CTIS Authorization Date
- 30-10-2025
Trial design
Placebo: SODIUM CHLORIDE PH. EUR. (IV infusion). Test arm: Donanemab (LY3002813) (IV infusion). Doses/schedules not specified in available data.-controlled Phase III trial in Spain, Poland.
- Comparator
- Placebo: SODIUM CHLORIDE PH. EUR. (IV infusion). Test arm: Donanemab (LY3002813) (IV infusion). Doses/schedules not specified in available data.
- Biomarker Stratified
- True, tau pathology (strata referenced: no-very low; low-medium); participants must meet amyloid scan (central read) criteria
- Target Sample Size
- 1062
- Trial Duration For Participant
- 532
Eligibility
Recruits 1062 No vulnerable population selected. The trial requires a study partner who will provide written informed consent to participate (Study Partner ICF documents are provided). Participant consent/assent handling relies on a study partner providing written informed consent; study partner and participant informed consent documents (including prescreening and APOE addenda) are available in site materials..
- Vulnerable Population
- No vulnerable population selected. The trial requires a study partner who will provide written informed consent to participate (Study Partner ICF documents are provided). Participant consent/assent handling relies on a study partner providing written informed consent; study partner and participant informed consent documents (including prescreening and APOE addenda) are available in site materials.
Inclusion criteria
- {"criterion_text":"- Participants must have gradual and progressive change in memory function reported by participants or informants for ≥ 6 months\n- Participants must have an MMSE score of 20 to 28 (inclusive) at screening\n- Participants must meet amyloid scan (central read) criteria\n- Participants must have a study partner who will provide written informed consent to participate"}
Exclusion criteria
- {"criterion_text":"- Participants must not have contraindications to MRI or PET scans"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from Baseline on the Integrated Alzheimer’s Disease Rating Scale (iADRS) in at least one of the low-medium tau pathology population or no-very low and low-medium tau pathology populations. [Time Frame: Baseline, Week 76]","definition_or_measurement_approach":"Change from baseline on the Integrated Alzheimer’s Disease Rating Scale (iADRS); measured at Baseline and at Week 76; primary analysis compares donanemab versus placebo in specified tau-pathology population(s) (low-medium tau; or no-very low and low-medium tau populations)."}
Recruitment
- Registry Or Advocacy Recruitment
- True, Fundacio Ace Institut Catala De Neurociencies Aplicades (listed as a patient organisation/association site and contact)
- Planned Sample Size
- 1062
- Recruitment Window Months
- 31
- Consent Approach
- A study partner is required and will provide written informed consent to participate (Study Partner ICF). Participant-facing informed consent forms (Main ICF) and prescreening ICFs are provided; addenda (e.g., APOE disclosure) and study partner ICFs are available. Published ICF documents are available in multiple languages (English, Polish, Spanish as indicated by provided document versions).
Methods
- Letter to doctors / Doctor referral (document: K2_Recruitment material_Letter Doctor Referral) - channel: referral letters to physicians; target audience: referring clinicians / memory clinics (documents associated with Member State applications).
- Poster (document: K2_Recruitment material_Poster) - channel: printed posters; target audience: potential participants and caregivers / public-facing clinic areas.
- Trial Brochure / Patient-facing brochure (documents: K2_Recruitment material_Trial Brochure_Redacted, Trial Brochure_PL) - channel: printed/digital brochure; target audience: patients and study partners.
- Patient screening, recruitment and retention support (documented third-party role: Patient Screening Recruitment and Retention) - channel: vendor-supported recruitment activities; target audience: potential participants and study partners.
- Participant contact card and other participant-facing materials (document: L2_Other subject information material_Study Participant Contact Card) - channel: site-distributed materials for participants and caregivers.
- Prescreening informed consent materials (document: L1_SIS and ICF_Prescreening ICF) - channel: prescreening ICF used during initial contact / screening.
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 170
Spain
- Earliest CTIS Part Ii Submission Date
- 22-09-2025
- Latest Decision Or Authorization Date
- 25-03-2026
- Processing Time Days
- 184
- Number Of Sites
- 8
- Number Of Participants
- 35
Sites
- Site Name
- Fundacio Ace Institut Catala De Neurociencies Aplicades
- Principal Investigator Name
- Mercè Boada Rovira
- Principal Investigator Email
- mboadatrials@fundacioace.org
- Contact Person Name
- Mercè Boada Rovira
- Contact Person Email
- mboadatrials@fundacioace.org
- Site Name
- Hospital De La Santa Creu I Sant Pau
- Department Name
- Memory Unit
- Principal Investigator Name
- Juan Fortea Ormaechea
- Principal Investigator Email
- jforteaac@santpau.cat
- Contact Person Name
- Juan Fortea Ormaechea
- Contact Person Email
- jforteaac@santpau.cat
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neurology
- Principal Investigator Name
- Miquel Baquero Toledo
- Principal Investigator Email
- baquero_miq@gva.es
- Contact Person Name
- Miquel Baquero Toledo
- Contact Person Email
- baquero_miq@gva.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Alzheimer's disease and other cognitive disorders unit
- Principal Investigator Name
- Albert Llado Plarrumani
- Principal Investigator Email
- allado@clinic.cat
- Contact Person Name
- Albert Llado Plarrumani
- Contact Person Email
- allado@clinic.cat
- Site Name
- Barcelonabeta Brain Research Center
- Department Name
- Neurology
- Principal Investigator Name
- Ana Fernández Arcos
- Principal Investigator Email
- afernandeza@barcelonabeta.org
- Contact Person Name
- Ana Fernández Arcos
- Contact Person Email
- afernandeza@barcelonabeta.org
- Site Name
- Hospital Universitari De Santa Maria
- Department Name
- Cognitive Impairment Unit
- 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 General De Catalunya
- Department Name
- Neurology
- Principal Investigator Name
- Ernest Balaguer
- Principal Investigator Email
- ebalaguer@quironsalud.es
- Contact Person Name
- Ernest Balaguer
- Contact Person Email
- ebalaguer@quironsalud.es
- Site Name
- Hospital Universitario Dr Peset Aleixandre
- Department Name
- Neurology
- Principal Investigator Name
- Lamberto Landete Pascual
- Principal Investigator Email
- landete.investigacion@gmail.com
- Contact Person Name
- Lamberto Landete Pascual
- Contact Person Email
- landete.investigacion@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 15-10-2025
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 159
- Number Of Sites
- 10
- Number Of Participants
- 135
Sites
- Site Name
- Ilkowski I Partnerzy sp.p. Lekarzy
- Principal Investigator Name
- Jan Ilkowski
- Principal Investigator Email
- jan.ilkowski@neurokard.pl
- Contact Person Name
- Jan Ilkowski
- Contact Person Email
- jan.ilkowski@neurokard.pl
- Site Name
- Centrum Medyczne Neuroprotect
- Principal Investigator Name
- Maciej Czarnecki
- Principal Investigator Email
- maciej.czarnecki@neuroprotect.pl
- Contact Person Name
- Maciej Czarnecki
- Contact Person Email
- maciej.czarnecki@neuroprotect.pl
- Site Name
- Neuro-Care Sp. z o.o. sp.k.
- Principal Investigator Name
- Gabriela Kłodowska
- Principal Investigator Email
- GabrielaKlodowska@neuro-care.pl
- Contact Person Name
- Gabriela Kłodowska
- Contact Person Email
- GabrielaKlodowska@neuro-care.pl
- Site Name
- Centrum Badan Klinicznych Pi-House Sp. z o.o.
- Principal Investigator Name
- Katarzyna Binkowska-Michalik
- Principal Investigator Email
- k.binkmich@pihouse.pl
- Contact Person Name
- Katarzyna Binkowska-Michalik
- Contact Person Email
- k.binkmich@pihouse.pl
- Site Name
- Wrocławskie Centrum Alzheimerowskie
- Principal Investigator Name
- Marzena Zboch
- Principal Investigator Email
- zbochm@poczta.onet.pl
- Contact Person Name
- Marzena Zboch
- Contact Person Email
- zbochm@poczta.onet.pl
- Site Name
- Diamond Clinic Sp. z o.o.
- Principal Investigator Name
- Sylwia Bukowczan
- Principal Investigator Email
- s.bukowczan@diamondclinic.eu
- Contact Person Name
- Sylwia Bukowczan
- Contact Person Email
- s.bukowczan@diamondclinic.eu
- Site Name
- Euromedis Sp. z o.o.
- Principal Investigator Name
- Marcin Ratajczak
- Principal Investigator Email
- marcin.ratajczak@euromedis.pl
- Contact Person Name
- Marcin Ratajczak
- Contact Person Email
- marcin.ratajczak@euromedis.pl
- Site Name
- Centrum Medyczne Neuromed Sp. z o.o.
- Principal Investigator Name
- Pawel Lisewski
- Principal Investigator Email
- lisewski.p@gmail.com
- Contact Person Name
- Pawel Lisewski
- Contact Person Email
- lisewski.p@gmail.com
- Site Name
- Revit Sp. z o.o.
- Principal Investigator Name
- Jacek Dobryniewski
- Principal Investigator Email
- jacekdobryniewski@gmail.com
- Contact Person Name
- Jacek Dobryniewski
- Contact Person Email
- jacekdobryniewski@gmail.com
- Site Name
- Ul. Pawla Kolodzieja 8 (Neuro-Care location listed separately)
Sponsor
Primary sponsor
- Full Name
- Eli Lilly & Co.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Iqvia Biotech LLC
- Responsibilities
- code:1
- Name
- Syneos Health Inc.
- Responsibilities
- code:11
- Name
- Bioclinica Inc.
- Responsibilities
- code:4
- Name
- Labcorp Central Laboratory Services SARL
- Responsibilities
- Central Laboratory
Third parties
- {"country":"Sweden","full_name":"Sahlgrenska University Hospital-Vaestra Goetalandsregionen","duties_or_roles":"code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Linguistically Validated Translations; code:6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"R&G US Inc.","duties_or_roles":"code:10","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Screening Recruitment and Retention","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Laboratory","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Early Development Laboratories Inc.","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Invicro LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"code:4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"code:10","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code:11","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cogstate Inc.","duties_or_roles":"Study Development Conduct, Central Rater; code:6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Techdata Service Company LLC","duties_or_roles":"code:10","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- Donanemab
- Active Substance
- DONANEMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- IV infusion
- Route
- IV infusion
- Investigational Product Name
- Florbetapir F18
- Active Substance
- FLORBETAPIR (18F)
- Modality
- Radiopharmaceutical
- Routes Of Administration
- IV infusion
- Route
- IV infusion
- Maximum Dose
- 29.72 (total max amount unit indicated in dataset)
- Investigational Product Name
- Flortaucipir F18
- Active Substance
- FLORTAUCIPIR (18F)
- Modality
- Radiopharmaceutical
- Routes Of Administration
- IV infusion
- Route
- IV infusion
- Maximum Dose
- 9.10 (total/max amount unit indicated in dataset)
- Investigational Product Name
- SODIUM CHLORIDE PH. EUR.
- Active Substance
- SODIUM CHLORIDE PH. EUR.
- Modality
- Other
- Routes Of Administration
- IV infusion
- Route
- IV infusion
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