A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

Alzheimer Disease Clinical Trial

Official title:

Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

• Verified date: April 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
• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Brain Diseases
• Central Nervous System Diseases
• Dementia
• Mental Disorders
• Nervous System Diseases
• Neurocognitive Disorders
• Neurodegenerative Diseases
• Tauopathies

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	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 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	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 Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
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

External Links

•   A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)