A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
- Conditions
- Alzheimer DiseaseDementiaNeurocognitive DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesMental DisordersNeurodegenerative Diseases
- Interventions
- Drug: Placebo
- Registration Number
- NCT05508789
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The reason for this study is to assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.
- Detailed Description
TRAILBLAZER-ALZ 5 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain tau pathology.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1500
-
Gradual and progressive change in memory function reported by the participant or informant for ≥6 months
-
A MMSE score of 20 to 28 (inclusive) at Day 601 or 1.
-
Meet flortaucipir F18 scan (central read) criteria
-
Meet florbetapir F18 scan (central read) criteria
-
Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to the study or be available by telephone at designated times.
-
A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered.
-
If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments.
-
Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments
- AEs and concomitant medications
- CDR, and
- ADCS-ADL
-
Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization.
- Has significant neurological disease affect the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
- Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months.
- History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread.
- Contraindication to MRI or PET scans
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Donanemab Donanemab Participants will receive donanemab intravenously (IV) Placebo Placebo Participants will receive placebo IV
- Primary Outcome Measures
Name Time Method Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Baseline, Week 76 Change from Baseline on the iADRS in at least one of 'the low-medium tau pathology population or the overall population'.
- Secondary Outcome Measures
Name Time Method Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Baseline, Week 76 Change from Baseline CDR-SB in at least one of 'the low-medium tau pathology population or the overall population'.
Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs) Week 76 Change from Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) Baseline, Week 76 Change from baseline in the RUD-Lite in at least one of 'the low-medium tau pathology population or the overall population'.
Change from Baseline in Neuropsychiatric Inventory (NPI) Baseline, Week 76 Change from baseline in the NPI in at least one of 'the low-medium tau pathology population or the overall population'.
Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale ADAS-Cog13 Score Baseline, Week 76 Change from Baseline on the ADAS-Cog13 Score in at least one of 'the low-medium tau pathology population or the overall population'.
Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living ADCS-iADL Score Baseline, Week 76 Change from Baseline ADCS-iADL Score in at least one of 'the low-medium tau pathology population or the overall population'.
Change from Baseline on the Mini Mental State Examination (MMSE) Score Baseline, Week 76 Change from Baseline on the MMSE Score in at least one of 'the low-medium tau pathology population or the overall population'.
Change from Baseline in Amyloid Plaque Deposition as by Florbetapir F18 Positron Emission Tomography (PET) Scan Baseline, Week 76 Pharmacokinetics (PK): Average Serum Concentration of Donanemab Baseline to Week 76 Change from Baseline in Quality of Life in Alzheimer's Disease (QOL-AD) Baseline, Week 76 Change from baseline in the QoL-AD in at least one of 'the low-medium tau pathology population or the overall population'.
Trial Locations
- Locations (123)
Clinica Privada Banfield
🇦🇷Banfield, Buenos Aires, Argentina
IDIM - Instituto de Investigaciones Metabólicas
🇦🇷Ciudad de Buenos Aires, Buenos Aires, Argentina
INSA Instituto de Neurociencia San Agustin
🇦🇷La Plata, Buenos Aires, Argentina
Instituto De Investigaciones Clinicas Quilmes
🇦🇷Quilmes, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷ABB, Ciudad Autónoma De Buenos Aires, Argentina
Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Stat Research S.A.
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
CIPREC
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Mautalen Salud e Investigación
🇦🇷Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
🇦🇷Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
INECO Neurociencias Oroño
🇦🇷Rosario, Santa Fe, Argentina
Instituto Geriatrico Nuestra Señora de Las Nieves
🇦🇷Buenos Aires, Argentina
Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
🇦🇷Buenos Aires, Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
🇦🇷Buenos Aires, Argentina
Centro de Investigaciones Metabólicas (CINME)
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Centro Médico Arsema
🇦🇷Ciudad Autónoma de Buenos Aires, Argentina
Emeritus Research
🇦🇺Botany, New South Wales, Australia
Central Coast Neurosciences Research
🇦🇺Erina, New South Wales, Australia
Southern Neurology
🇦🇺Kogarah, New South Wales, Australia
St Vincent's Hospital
🇦🇺Sydney, New South Wales, Australia
KARA Institute for Neurological Diseases
🇦🇺Sydney, New South Wales, Australia
Central Coast Neurosciences Research (Tumbi Umbi)
🇦🇺Tumbi Umbi, New South Wales, Australia
The Prince Charles Hospital
🇦🇺Brisbane, Queensland, Australia
The Queen Elizabeth Hospital
🇦🇺Woodville, South Australia, Australia
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
NeuroCentrix
🇦🇺Carlton, Victoria, Australia
Austin Health
🇦🇺Ivanhoe, Victoria, Australia
HammondCare
🇦🇺Malvern, Victoria, Australia
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
The Royal Melbourne Hospital
🇦🇺Parkville, Victoria, Australia
Australian Alzheimer's Research Foundation Inc.
🇦🇺Nedlands, Western Australia, Australia
Neurodegenerative Disorders Research
🇦🇺Perth, Western Australia, Australia
Beijing Hospital
🇨🇳Beijing, Beijing, China
Beijing ChaoYang Hospital
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital Affiliate of Capital University
🇨🇳Beijing, Beijing, China
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Tiantan Hospital Affiliated to Capital Medical University
🇨🇳Beijing, Beijing, China
Beijing Anding Hospital - Affiliated Capital University of Medical Science
🇨🇳Beijing, Beijing, China
Beijing Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Peking University Sixth Hospital
🇨🇳Haidian District, Beijing, China
The First Afffiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Fujian Medical University Union Hospital-1 Bingfanglou
🇨🇳Fuzhou Fujian, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China
The First Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Fourth Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Tongji Hospital Tongji Medical,Science & Technology
🇨🇳Wuhan, Hubei, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Nanjing Brain Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Wuxi People's Hospital
🇨🇳Wuxi, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical College
🇨🇳Xuzhou, Jiangsu, China
Xuzhou Central Hospital
🇨🇳Xuzhou, Jiangsu, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army
🇨🇳Xi'an, Shaanxi, China
Xianyang Hospital of Yan'an University
🇨🇳Xianyang, Shaanxi, China
Jinan Central Hospital
🇨🇳Jinan, Shandong, China
Shanghai Mental Health Center
🇨🇳Shanghai, Shanghai, China
Shanghai Sixth People's Hospital
🇨🇳Shanghai, Shanghai, China
Huashan Hospital Affiliated Fudan University
🇨🇳Shanghai, Shanghai, China
Shanghai Tongji Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
West China Hospital, Sichuan University
🇨🇳Cheng Du, Sichuan, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
Tianjin Huanhu Hospital
🇨🇳Tianjin, Tianjin, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital
🇨🇳Hangzhou, Zhejiang, China
The Second Affiliated hospital of Zhejiang University school of medicine
🇨🇳Hangzhou, Zhejiang, China
Shanghai East Hospital
🇨🇳Shanghai, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, China
Inha University Hospital
🇰🇷Incheon, Incheon-gwangyeoksi [Incheon], Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju-si, Kwangju-Kwangyǒkshi, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Guri-si, Kyǒnggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Kyǒnggi-do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon-si, Kyǒnggi-do, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Pusan-Kwangyǒkshi, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Konkuk University Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Ewha Womans University Seoul Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Chungnam national university hospital
🇰🇷Jung-gu, Taejǒn-Kwangyǒkshi, Korea, Republic of
Chang Gung Memorial Hospital at Kaohsiung
🇨🇳Kaohsiung Niao-Sung Dist, Kaohsiung, Taiwan
Cardinal Tien Hospital
🇨🇳New Taipei City, New Taipei, Taiwan
New Taipei Municipal TuCheng Hospital
🇨🇳New Taipei City, New Taipei, Taiwan
Tri-Service General Hospital
🇨🇳Taipei City, Taipei, Taiwan
National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region
🇨🇳Douliu City, Yunlin, Taiwan
Taipei Medical University Shuang Ho Hospital
🇨🇳New Taipei, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan
Re:Cognition Health - Bristol
🇬🇧Bristol, Bristol, City Of, United Kingdom
Dementia Research Unit
🇬🇧Crowborough, East Sussex, United Kingdom
Surrey and Borders Partnership NHS Foundation Trust
🇬🇧Chertsey, England, United Kingdom
St. George's Hospital
🇬🇧London, England, United Kingdom
University College London Hospital
🇬🇧London, England, United Kingdom
Charing Cross Hospital
🇬🇧London, Hammersmith And Fulham, United Kingdom
Moorgreen Hospital
🇬🇧Southampton, Hampshire, United Kingdom
Re:Cognition Health - Winchester
🇬🇧Winchester, Hampshire, United Kingdom
Royal Preston Hospital
🇬🇧Preston, Lancashire, United Kingdom
Re:Cognition Health - London
🇬🇧London, London, City Of, United Kingdom
Queen's Medical Centre, Nottingham University Hospitals
🇬🇧Nottinghamshire, Nottingham, United Kingdom
Re:Cognition Health - Guildford
🇬🇧Guildford, Reading, United Kingdom
The Rice Centre - Royal United Hospital
🇬🇧Bath, United Kingdom
Re:Cognition Health - Birmingham
🇬🇧Birmingham, United Kingdom
Re:Cognition Health - Plymouth
🇬🇧Plymouth, United Kingdom