Clinical trial NCT05508789: A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)
Official title: Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Keywords: Alzheimer's
Dementia
Cognitive Impairment
Amyloid Plaque
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2022-08-19
Enrollment: 1500
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) and the presence of AD pathology.

Eligibility criteria: 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 screening visit.
* Meet amyloid 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 affecting 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.

Primary outcomes:
measure: Change from Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS)
timeFrame: Baseline, Week 76
Secondary outcomes:
measure: Change from Baseline on the iADRS
timeFrame: Baseline, Week 76
measure: Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
timeFrame: Baseline, Week 76
measure: Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) Score
timeFrame: Baseline, Week 76
measure: Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score
timeFrame: Baseline, Week 76
measure: Change from Baseline on the Mini Mental State Examination (MMSE) Score
timeFrame: Baseline, Week 76
measure: Change from Baseline in Amyloid Plaque Deposition as by Amyloid Positron Emission Tomography (PET) Scan
timeFrame: Baseline, Week 76
measure: Pharmacokinetics (PK): Trough Serum Concentration of Donanemab
timeFrame: Baseline to Week 76
measure: Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs)
timeFrame: Week 76
Other outcomes:
Locations:
city: Banfield
country: Argentina
facility: Clinica Privada Banfield
state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: IDIM - Instituto de Investigaciones Metabólicas
state: Buenos Aires
city: La Plata
country: Argentina
facility: INSA Instituto de Neurociencia San Agustin
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Instituto De Investigaciones Clinicas Quilmes
state: Buenos Aires
city: ABB
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Stat Research S.A.
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: CIPREC
state: Ciudad Autónoma De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Mautalen Salud e Investigación
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aires
city: Rosario
country: Argentina
facility: INECO Neurociencias Oroño
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Instituto Geriatrico Nuestra Señora de Las Nieves
city: Buenos Aires
country: Argentina
facility: Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)
city: Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC)
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro Médico Arsema
city: Botany
country: Australia
facility: Emeritus Research
state: New South Wales
city: Erina
country: Australia
facility: Central Coast Neurosciences Research
state: New South Wales
city: Kogarah
country: Australia
facility: Southern Neurology
state: New South Wales
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Sydney
country: Australia
facility: KARA Institute for Neurological Diseases
state: New South Wales
city: Tumbi Umbi
country: Australia
facility: Central Coast Neurosciences Research (Tumbi Umbi)
state: New South Wales
city: Brisbane
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Carlton
country: Australia
facility: NeuroCentrix
state: Victoria
city: Ivanhoe
country: Australia
facility: Austin Health
state: Victoria
city: Malvern
country: Australia
facility: HammondCare
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Australian Alzheimer's Research Foundation Inc.
state: Western Australia
city: West Perth
country: Australia
facility: Neurodegenerative Disorders Research
state: Western Australia
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing ChaoYang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Affiliate of Capital University
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital Affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Anding Hospital - Affiliated Capital University of Medical Science
state: Beijing
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Haidian District
country: China
facility: Peking University Sixth Hospital
state: Beijing
city: Chongqing
country: China
facility: The First Afffiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou Fujian
country: China
facility: Fujian Medical University Union Hospital-1 Bingfanglou
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical College
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Xi'an
country: China
facility: Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army
state: Shaanxi
city: Xianyang
country: China
facility: Xianyang Hospital of Yan'an University
state: Shaanxi
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital Affiliated Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated hospital of Zhejiang University school of medicine
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai East Hospital
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon-gwangyeoksi [Incheon]
city: Namdong-gu
country: Korea, Republic of
facility: Gachon University Gil Medical Center
state: Incheon-gwangyeoksi [Incheon]
city: Gwangju-si
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Kwangju-Kwangyǒkshi
city: Guri-si
country: Korea, Republic of
facility: Hanyang University Guri Hospital
state: Kyǒnggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyǒnggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Kyǒnggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
state: Pusan-Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
state: Seoul-teukbyeolsi [Seoul]
city: Jung-gu
country: Korea, Republic of
facility: Chungnam national university hospital
state: Taejǒn-Kwangyǒkshi
city: Wroclaw
country: Poland
facility: Wroclawskie Centrum Alzheimerowskie
state: Dolnośląskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne NEUROMED
state: Kujawsko-pomorskie
city: Warszawa
country: Poland
facility: Centrum Medyczne NeuroProtect
state: Mazowieckie
city: Krakow
country: Poland
facility: Diamond Clinic
state: Małopolskie
city: Białystok
country: Poland
facility: Podlaskie Centrum Psychogeriatrii
state: Podlaskie
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych PI-House sp. z o.o.
state: Pomorskie
city: Poznan
country: Poland
facility: Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
state: Wielkopolskie
city: Szczecin
country: Poland
facility: Centrum Medyczne Euromedis
state: Zachodniopomorskie
city: Katowice
country: Poland
facility: Klinika Neuro-Care
state: Śląskie
city: Barcelona
country: Spain
facility: Barcelonabeta Brain Research Center
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Fundació ACE
state: Barcelona [Barcelona]
city: Sant Cugat del Vallès
country: Spain
facility: Hospital Universitari General de Catalunya
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
state: Catalunya [Cataluña]
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalunya [Cataluña]
city: Lleida
country: Spain
facility: Hospital Universitari de Santa Maria
state: Lleida [Lérida]
city: Valencia
country: Spain
facility: Hospital Universitario Doctor Peset
state: Valenciana, Comunitat
city: València
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Kaohsiung Niao-Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung
state: Kaohsiung
city: New Taipei City
country: Taiwan
facility: Cardinal Tien Hospital
state: New Taipei
city: New Taipei City
country: Taiwan
facility: New Taipei Municipal TuCheng Hospital
state: New Taipei
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital
state: Taipei
city: Douliu City
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch Dou-Liou Region
state: Yunlin
city: New Taipei
country: Taiwan
facility: Taipei Medical University Shuang Ho Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch
city: Bristol
country: United Kingdom
facility: Re:Cognition Health - Bristol
state: Bristol, City Of
city: Crowborough
country: United Kingdom
facility: Dementia Research Unit
state: East Sussex
city: Chertsey
country: United Kingdom
facility: Surrey and Borders Partnership NHS Foundation Trust
state: England
city: London
country: United Kingdom
facility: St. George's Hospital
state: England
city: London
country: United Kingdom
facility: University College London Hospital
state: England
city: London
country: United Kingdom
facility: Charing Cross Hospital
state: Hammersmith And Fulham
city: Southampton
country: United Kingdom
facility: Moorgreen Hospital
state: Hampshire
city: Winchester
country: United Kingdom
facility: Re:Cognition Health - Winchester
state: Hampshire
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
state: Lancashire
city: London
country: United Kingdom
facility: Re:Cognition Health - London
state: London, City Of
city: Nottinghamshire
country: United Kingdom
facility: Queen's Medical Centre, Nottingham University Hospitals
state: Nottingham
city: Guildford
country: United Kingdom
facility: Re:Cognition Health - Guildford
state: Reading
city: Bath
country: United Kingdom
facility: The Rice Centre - Royal United Hospital
city: Birmingham
country: United Kingdom
facility: Re:Cognition Health - Birmingham
city: Plymouth
country: United Kingdom
facility: Re:Cognition Health - Plymouth
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: