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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05508789
Other study ID # 18442
Secondary ID I5T-MC-AACO2021-
Status Recruiting
Phase Phase 3
First received
Last updated
Start date October 10, 2022
Est. completion date April 30, 2027

Study information

Verified date June 2024
Source Eli Lilly and Company
Contact There may be multiple sites in this clinical trial. 1-877-CTLILL
Phone 1-317-615-4559
Email ClinicalTrials.gov@lilly.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Recruiting
Enrollment 1500
Est. completion date April 30, 2027
Est. primary completion date April 16, 2027
Accepts healthy volunteers No
Gender All
Age group 60 Years to 85 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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


Intervention

Drug:
Donanemab
Administered IV
Placebo
Administered IV

Locations

Country Name City State
Argentina Centro de Investigaciones Metabólicas (CINME) ABB Ciudad Autónoma De Buenos Aires
Argentina Clinica Privada Banfield Banfield Buenos Aires
Argentina Centro de Educación Médica e Investigaciones Clínicas (CEMIC) Buenos Aires
Argentina CIPREC Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM) Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI) Buenos Aires
Argentina Instituto Geriatrico Nuestra Señora de Las Nieves Buenos Aires
Argentina Mautalen Salud e Investigación Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina Stat Research S.A. Buenos Aires Ciudad Autónoma De Buenos Aires
Argentina Clinica Adventista Belgrano Caba 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 Centro de Investigaciones Metabólicas (CINME) Ciudad Autónoma de Buenos Aires Buenos Aires
Argentina IDIM - Instituto de Diagnóstico e 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 INECO Neurociencias Oroño Rosario Santa Fe
Australia Optimus Clinical Research Botany New South Wales
Australia Box Hill Hospital Box Hill Victoria
Australia The Prince Charles Hospital Brisbane Queensland
Australia NeuroCentrix Carlton Victoria
Australia Central Coast Neurosciences Research Erina New South Wales
Australia Delmont Private Hospital Glen Iris Victoria
Australia Austin Health Ivanhoe Victoria
Australia Southern Neurology Kogarah New South Wales
Australia HammondCare Malvern Victoria
Australia The Alfred Hospital Melbourne Victoria
Australia Australian Alzheimer's Research Foundation Inc. Nedlands Western Australia
Australia The Royal Melbourne Hospital Parkville Victoria
Australia Neurodegenerative Disorders Research Perth Western Australia
Australia KARA Institute for Neurological Diseases Sydney New South Wales
Australia St Vincent's Hospital Sydney New South Wales
Australia Central Coast Neurosciences Research (Tumbi Umbi) Tumbi Umbi New South Wales
Australia The Queen Elizabeth Hospital Woodville South Australia
China Beijing Anding Hospital - Affiliated Capital University of Medical Science Beijing Beijing
China Beijing ChaoYang Hospital Beijing Beijing
China Beijing Friendship Hospital Beijing Beijing
China Beijing Hospital Beijing Beijing
China Beijing Peking Union Medical College Hospital Beijing Beijing
China Beijing Tiantan Hospital Affiliated to Capital Medical University Beijing Beijing
China Chinese PLA General Hospital Beijing Beijing
China Xuanwu Hospital Capital Medical University Beijing Beijing
China The First Hospital of Jilin University Changchun Jilin
China The Second Xiangya Hospital of Central South University Changsha Hunan
China Xiangya Hospital Central South University Changsha Hunan
China West China Hospital of Sichuan University Cheng Du Sichuan
China Sichuan Provincial People's Hospital Chengdu Sichuan
China The First Afffiliated Hospital of Chongqing Medical University Chongqing Chongqing
China Fujian Medical University Union Hospital-1 Bingfanglou Fuzhou Fujian Fujian
China Guangdong Provincial People's Hospital Guangzhou Guangdong
China Guangzhou First People's Hospital Guangzhou Guangdong
China Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong
China The First Affiliated Hospital, Sun Yat-sen University Guangzhou Guangdong
China Peking University Sixth Hospital Haidian District Beijing
China Sir Run Run Shaw Hospital Hangzhou Zhejiang
China The First Affiliated Hospital, Zhejiang University Hangzhou Zhejiang
China The Second Affiliated hospital of Zhejiang University school of medicine Hangzhou Zhejiang
China Zhejiang Provincial People's Hospital Hangzhou Zhejiang
China The Fourth Hospital of Harbin Medical University Harbin Heilongjiang
China Jinan Central Hospital Jinan Shandong
China The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Nanjing Brain Hospital Nanjing Jiangsu
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 Huashan Hospital Affiliated Fudan University Shanghai Shanghai
China Shanghai East Hospital Shanghai
China Shanghai General Hospital Shanghai Shanghai
China Shanghai Mental Health Center Shanghai Shanghai
China Shanghai Sixth People's Hospital Shanghai Shanghai
China Shanghai Tongji Hospital Shanghai Shanghai
China Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai
China The First Hospital of Hebei Medical University Shijiazhuang
China The First Affiliated Hospital of Soochow University Suzhou Jiangsu
China The Second Affiliated Hospital of Soochow University Suzhou Jiangsu
China Tianjin Huanhu Hospital Tianjin Tianjin
China Tianjin Medical University General Hospital Tianjin Tianjin
China Renmin Hospital of Wuhan University Wuhan
China Tongji Hospital Tongji Medical,Science & Technology Wuhan Hubei
China Wuxi People's Hospital Wuxi Jiangsu
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 The Affiliated Hospital of Xuzhou Medical College Xuzhou Jiangsu
China Xuzhou Central Hospital Xuzhou Jiangsu
China Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu
Korea, Republic of Pusan National University Hospital Busan Pusan-Kwangyokshi
Korea, Republic of Hanyang University Guri Hospital Guri-si Kyonggi-do
Korea, Republic of Chonnam National University Hospital Gwangju-si Kwangju-Kwangyokshi
Korea, Republic of Ajou University Hospital Gyeonggi-do Yeongtong-gu
Korea, Republic of Inha University Hospital Incheon Incheon-gwangyeoksi [Incheon]
Korea, Republic of Chungnam national university hospital Jung-gu Taejon-Kwangyokshi
Korea, Republic of Gachon University Gil Medical Center Namdong-gu Incheon-gwangyeoksi [Incheon]
Korea, Republic of Seoul National University Bundang Hospital Seongnam Kyonggi-do
Korea, Republic of Seoul National University Bundang Hospital Seongnam Kyonggi-do
Korea, Republic of Asan Medical Center Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Ewha Womans University Seoul 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 Korea University Anam Hospital Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of Samsung Medical Center Seoul Seoul-teukbyeolsi [Seoul]
Korea, Republic of The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul Seoul-teukbyeolsi [Seoul]
Taiwan National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region Douliu City Yunlin
Taiwan Chang Gung Memorial Hospital at Kaohsiung Kaohsiung Niao-Sung Dist Kaohsiung
Taiwan Taipei Medical University Shuang Ho Hospital New Taipei
Taiwan Cardinal Tien Hospital New Taipei City New Taipei
Taiwan New Taipei Municipal TuCheng Hospital New Taipei City 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 City Taipei
Taiwan Tri-Service General Hospital Taipei City Taipei
Taiwan Chang Gung Medical Foundation-Linkou Branch Taoyuan
United Kingdom The Rice Centre - Royal United Hospital Bath
United Kingdom Re:Cognition Health - Birmingham Birmingham
United Kingdom Re:Cognition Health - Bristol Bristol Bristol, City Of
United Kingdom Surrey and Borders Partnership NHS Foundation Trust Chertsey England
United Kingdom Dementia Research Unit Crowborough East Sussex
United Kingdom Re:Cognition Health Guildford Guildford Reading
United Kingdom Charing Cross Hospital London Hammersmith And Fulham
United Kingdom Re:Cognition Health - London London London, City Of
United Kingdom St. George's Hospital London England
United Kingdom Queen's Medical Centre, Nottingham University Hospitals Nottinghamshire Nottingham
United Kingdom Re:Cognition Health - Plymouth Plymouth
United Kingdom Royal Preston Hospital Preston Lancashire
United Kingdom Moorgreen Hospital Southampton Hampshire
United Kingdom Re:Cognition Health - Winchester Winchester Hampshire

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Argentina,  Australia,  China,  Korea, Republic of,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Change from Baseline on the iADRS in at least one of 'the low-medium tau pathology population or the overall population'. Baseline, Week 76
Secondary Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) Change from Baseline CDR-SB in at least one of 'the low-medium tau pathology population or the overall population'. Baseline, Week 76
Secondary Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale ADAS-Cog13 Score Change from Baseline on the ADAS-Cog13 Score in at least one of 'the low-medium tau pathology population or the overall population'. Baseline, Week 76
Secondary Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living ADCS-iADL Score Change from Baseline ADCS-iADL Score in at least one of 'the low-medium tau pathology population or the overall population'. Baseline, Week 76
Secondary Change from Baseline on the Mini Mental State Examination (MMSE) Score Change from Baseline on the MMSE Score in at least one of 'the low-medium tau pathology population or the overall population'. Baseline, Week 76
Secondary Change from Baseline in Amyloid Plaque Deposition as by Florbetapir F18 Positron Emission Tomography (PET) Scan Baseline, Week 76
Secondary Pharmacokinetics (PK): Average Serum Concentration of Donanemab Baseline to Week 76
Secondary Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs) Week 76
Secondary Change from Baseline in Quality of Life in Alzheimer's Disease (QOL-AD) Change from baseline in the QoL-AD in at least one of 'the low-medium tau pathology population or the overall population'. Baseline, Week 76
Secondary Change from Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) Change from baseline in the RUD-Lite in at least one of 'the low-medium tau pathology population or the overall population'. Baseline, Week 76
Secondary Change from Baseline in Neuropsychiatric Inventory (NPI) Change from baseline in the NPI in at least one of 'the low-medium tau pathology population or the overall population'. Baseline, Week 76
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