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Recruiting NCT07589595

A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

Phase II Interventional Cognitive Dysfunction Lewy Body Disease Synucleinopathies Amyloid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Donanemab, Placebo.
Who it may be relevant to
Registry conditions: Cognitive Dysfunction, Lewy Body Disease, Synucleinopathies, Amyloid. Basic parameters: 55 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Japan, South Korea, Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology

Overview

The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.

Interventions

  • Drug Donanemab
    Donanemab administered IV
  • Drug Placebo
    Placebo administered IV

Primary outcome measures

  • Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB) [Time frame: Baseline through Week 52]
Secondary outcome measures (9)
  • Change from Baseline for Integrated Alzheimer's Disease Rating Scale (iADRS) [Time frame: Baseline through Week 52]
  • Change from Baseline for Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13 items (ADAS-Cog13) [Time frame: Baseline through Week 52]
  • Change from Baseline for Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living Inventory (ADCS-iADL) [Time frame: Baseline through Week 52]
  • Time to Clinical Progression of Dementia as Measured by Clinical Dementia Rating - Global Score (CDR-GS) [Time frame: Baseline through Week 52]
  • Change from Baseline in Brain Amyloid Plaque Levels [Time frame: Baseline through Week 52]
  • Trough Concentration at Steady State [Time frame: Baseline through Week 52]
  • Maximum Concentration at Steady State [Time frame: Baseline through Week 52]
  • Antidrug Antibodies (ADA) Against Donanemab [Time frame: Baseline through Week 52]
  • Frequency of Neutralizing Antibodies to Donanemab Treatment-Emergent ADA-Positive Participants [Time frame: Baseline through Week 52]

Eligibility criteria

Inclusion criteria

  • Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months.
  • Have least 1 core clinical feature of dementia with Lewy bodies (DLB).
  • Have a score ≥20 on Montreal Cognitive Assessment (MoCA).
  • Meet plasma P-tau217 criteria.
  • Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology.
  • Have a CSF result consistent with the presence of alpha-synuclein pathology.
  • Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.

Exclusion criteria

  • Have a disease or condition that could interfere with this study or is a current serious or unstable illness.
  • Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study.
  • Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study.
  • Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions.
  • Have previously received amyloid-targeting therapy.
  • Active immunization against amyloid-beta.
  • Have a centrally read MRI that does not meet study entry criteria.
  • Have contraindication to MRI or PET scans.
  • Have any contraindication to lumbar puncture.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 42 centers
  • TrialSphere Corp — Chandler
  • HonorHealth Research Institute — Scottsdale
  • Profound Research LLC — Carlsbad
  • Irvine Clinical Research — Irvine
  • UCSD - Altman Clinical and Translational Research Institute (ACTRI) — La Jolla
  • Stanford Neuroscience Health Center — Palo Alto
  • CenExel Rocky Mountain Clinical Research — Englewood
  • Ki Health Partners, LLc, dba New England Institute for Clinical Research — Stamford
  • … and 34 more centers
Japan · 18 centers
  • Memory Clinic Ochanomizu — Bunkyō City
  • Shonan Keiiku Hospital — Fujisawa
  • Hyogo Prefectural Harima-Himeji General Medical Center — Himeji
  • Inage Neurology and Memory Clinic — Inage
  • Nippon Medical School Musashi Kosugi Hospital — Kawasaki
  • St. Marianna University Hospital — Kawasaki
  • Kobe University Hospital — Kobe
  • Juntendo Tokyo Koto Geriatric Medical Center — Kōtoku
  • … and 10 more centers
Taiwan · 6 centers
  • Taipei Medical University Shuang Ho Hospital — New Taipei City
  • New Taipei Municipal TuCheng Hospital — New Taipei City
  • National Cheng Kung University Hospital — Tainan
  • National Taiwan University Hospital — Taipei
  • Taipei Veterans General Hospital — Taipei
  • Chang Gung Medical Foundation-Linkou Branch — Taoyuan
South Korea · 5 centers
  • Gangnam Severance Hospital, Yonsei University Health System — Gangnam-gu
  • Inha University Hospital — Incheon
  • Hanyang University Seoul Hospital — Seoul
  • Konkuk University Medical Center — Seoul
  • Ewha Womans University Mokdong Hospital — Seoul

Identifiers

NCT: NCT07589595 · 27790 · I5T-MC-AACV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗