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

May 11, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: LillyTrials@Lilly.com

Study Contact Backup

Study Locations

  • Japan
      • Bunkyō City, Japan, 113-0034
        • Memory Clinic Ochanomizu
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Takashi Asada
      • Fujisawa, Japan, 252-0816
        • Shonan Keiiku Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yasuo Terayama
      • Himeji, Japan, 670-8560
        • Hyogo Prefectural Harima-Himeji General Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kenichi Shimada
      • Inage, Japan, 263-0043
        • Inage Neurology and Memory Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Yasumasa Yoshiyama
      • Kawasaki, Japan, 216-8511
        • St. Marianna University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Koji Kasanuki
      • Kawasaki, Japan, 211-8533
        • Nippon Medical School Musashi Kosugi Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kentaro Suzuki
      • Kobe, Japan, 650-0017
        • Kobe University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hisatomo Kowa
      • Kurashiki, Japan, 710-0813
        • Katayama Medical Clinic
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Sadao Katayama
      • Kōtoku, Japan, 136-0075
        • Juntendo Tokyo Koto Geriatric Medical Center
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kenya Nishioka
      • Nagoya, Japan, 466-8560
        • Nagoya University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Masahisa Katsuno
      • Tachikawa, Japan, 190-8531
        • Tachikawa Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Hidenori Hattori
      • Toride, Japan, 302-0004
        • Memory Clinic Toride
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Youshun Boku
      • Yokohama, Japan, 236-0037
        • Yokohama Minami Kyosai Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Shigeru Koyano
      • Yufu, Japan, 879-5593
        • Oita University Hospital
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Noriyuki Kimura
      • tabashi City, Japan, 173-0015
        • Tokyo Metropolitan Institute for Geriatrics and Gerontology
        • Principal Investigator:
          • Atsushi Iwata
        • Contact:
          • Phone Number: 81120023812
      • Ōbu, Japan, 474-8511
        • National Center for Geriatrics and Gerontology
        • Contact:
          • Phone Number: 81120023812
        • Principal Investigator:
          • Kazunori Imai
  • South Korea
      • Gangnam-gu, South Korea, 06273
        • Gangnam Severance Hospital, Yonsei University Health System
        • Contact:
          • Phone Number: +82-10-3000-4975
        • Principal Investigator:
          • Hanna Cho
      • Incheon, South Korea, 22332
        • Inha University Hospital
        • Principal Investigator:
          • Seong Hye Choi
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
        • Principal Investigator:
          • Byoung Seok Ye
        • Contact:
          • Phone Number: 82-10-2505-9280
      • Seoul, South Korea, 05030
        • Konkuk University Medical Center
        • Principal Investigator:
          • Seol-Heui Han
      • Seoul, South Korea, 07985
        • Ewha Womans University Mokdong Hospital
        • Principal Investigator:
          • Geon Ha Kim
      • Seoul, South Korea, 04763
        • Hanyang University Seoul Hospital
        • Principal Investigator:
          • Hee-Jin Kim
        • Contact:
          • Phone Number: 82-2-2290-8374
  • Taiwan
      • New Taipei City, Taiwan, 235
        • Taipei Medical University Shuang Ho Hospital
        • Principal Investigator:
          • Chaur-Jong Hu
        • Contact:
          • Phone Number: 02224900888819
      • New Taipei City, Taiwan, 236
        • New Taipei Municipal TuCheng Hospital
        • Principal Investigator:
          • Jung Lung Hsu
        • Contact:
          • Phone Number: 03-3281200
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
        • Principal Investigator:
          • MingChyi Pai
        • Contact:
          • Phone Number: 886 972401434
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
        • Principal Investigator:
          • Cheng-Hsuan Li
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
        • Contact:
          • Phone Number: 886228757578
        • Principal Investigator:
          • Jong-Ling Fuh
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch
        • Principal Investigator:
          • Yi-Chun Chen
        • Contact:
          • Phone Number: +886-3-3281200 ext 8347
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85286
        • TrialSphere Corp
        • Principal Investigator:
          • Hemant Pandey
        • Contact:
          • Phone Number: 480-508-1038
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth Research Institute
        • Principal Investigator:
          • Todd Levine
    • California
      • Carlsbad, California, United States, 92011
        • Profound Research LLC
        • Contact:
          • Phone Number: 760-631-3000
        • Principal Investigator:
          • Benjamin Frishberg
      • Irvine, California, United States, 92614
        • Irvine Clinical Research
        • Contact:
          • Phone Number: 949-753-1663
        • Principal Investigator:
          • Edward Zamrini
      • La Jolla, California, United States, 92037
        • UCSD - Altman Clinical and Translational Research Institute (ACTRI)
        • Principal Investigator:
          • Stephanie Lessig
      • Palo Alto, California, United States, 94304
        • Stanford Neuroscience Health Center
        • Principal Investigator:
          • Irina Skylar-Scott
        • Contact:
          • Phone Number: 818-398-9855
    • Colorado
      • Englewood, Colorado, United States, 80113
        • CenExel Rocky Mountain Clinical Research
        • Principal Investigator:
          • Meagen Salinas
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Ki Health Partners, LLc, dba New England Institute for Clinical Research
        • Contact:
          • Phone Number: 203-914-1903
        • Principal Investigator:
          • Peter McAllister
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research Institute
        • Contact:
          • Phone Number: 561-968-2933
        • Principal Investigator:
          • Linda Pao
      • Aventura, Florida, United States, 33180
        • VIN - Aventura
        • Contact:
          • Phone Number: 305-933-5993
        • Principal Investigator:
          • Jonathan Cross
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
        • Contact:
          • Phone Number: 561-374-8461
        • Principal Investigator:
          • Paayal Patel
      • Fort Myers, Florida, United States, 33912
        • Neuropsychiatric Research Center of Southwest Florida
        • Contact:
          • Phone Number: 239-939-7777
        • Principal Investigator:
          • John Huffaker
      • Gainesville, Florida, United States, 32608
        • Norman Fixel Institute for Neurological Diseases (FIND)
        • Principal Investigator:
          • Bhavana Patel
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida
        • Principal Investigator:
          • Neill Graff-Radford
      • Maitland, Florida, United States, 32751
        • K2 Medical Research ORLANDO
        • Contact:
          • Phone Number: 407-500-5252
        • Principal Investigator:
          • Sheila Baez-Torres
      • Miami, Florida, United States, 33175
        • BRP-Kendal Lakes
        • Principal Investigator:
          • Jose Gonzalez
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
        • Principal Investigator:
          • Anette Nieves
        • Contact:
          • Phone Number: 352-629-5800
      • Orlando, Florida, United States, 32803
        • Charter Research - Orlando
        • Contact:
          • Phone Number: 407-337-1000
        • Principal Investigator:
          • Diana Balsalobre
      • Tampa, Florida, United States, 33609
        • Axiom Brain Health LLC
        • Contact:
          • Phone Number: 813-353-9613
        • Principal Investigator:
          • Susan Steen
      • West Palm Beach, Florida, United States, 33407
        • Palm Beach Neurology
        • Contact:
          • Phone Number: 561-845-0500
        • Principal Investigator:
          • Paul Winner
      • Winter Park, Florida, United States, 32789
        • Conquest Research
        • Contact:
          • Phone Number: 407-916-0060
        • Principal Investigator:
          • Malisa Agard
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health Neuroscience Center
        • Contact:
          • Phone Number: 317-963-7402
        • Principal Investigator:
          • Jared Brosch
    • Kansas
      • Fairway, Kansas, United States, 66205
        • The University of Kansas - Clinical Research Center
        • Principal Investigator:
          • Ryan Townley
        • Contact:
          • Phone Number: 913-574-0976
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Massachusetts General Hospital - Charlestown
        • Principal Investigator:
          • Anna Goodheart
      • Foxborough, Massachusetts, United States, 02035
        • Neurology Center of New England
        • Principal Investigator:
          • Salvatore Napoli
        • Contact:
          • Phone Number: 781-551-5812
      • Plymouth, Massachusetts, United States, 02360
        • Headlands Eastern MA LLC
        • Contact:
          • Phone Number: 978-831-8041
        • Principal Investigator:
          • Kinan Hreib
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Quest Research Institute
        • Contact:
          • Phone Number: 248-957-8940
        • Principal Investigator:
          • Aaron Ellenbogen
    • Minnesota
      • Golden Valley, Minnesota, United States, 55427
        • Struthers Parkinson's Center
        • Principal Investigator:
          • Sotirios Parashos
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester, Minnesota
        • Principal Investigator:
          • Jonathan Graff-Radford
    • Missouri
      • Bolivar, Missouri, United States, 65613
        • Citizens Memorial Hospital District
        • Contact:
          • Phone Number: 417-328-7781
        • Principal Investigator:
          • Curtis Schreiber
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
        • Principal Investigator:
          • Aimee Pierce
      • Portland, Oregon, United States, 97210
        • Summit Headlands
        • Principal Investigator:
          • Scott Losk
        • Contact:
          • Phone Number: 503-279-8252
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Pennsylvania Hospital
        • Principal Investigator:
          • Rebecca Williamson
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • K2 Medical Research - East Providence
        • Contact:
          • Phone Number: 401-435-8950
        • Principal Investigator:
          • john stoukides
    • Texas
      • Beaumont, Texas, United States, 77702
        • Gadolin Research
        • Contact:
          • Phone Number: 409-331-6040
        • Principal Investigator:
          • Kandasami Senthilkumar
      • Dallas, Texas, United States, 75231
        • Kerwin Medical Center
        • Principal Investigator:
          • Alka Khera
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
        • Principal Investigator:
          • Juan Toledo Atucha
      • Houston, Texas, United States, 77054
        • The University of Texas Health Science Center at Houston
        • Contact:
          • Phone Number: 713-486-0536
        • Principal Investigator:
          • David Hunter
      • Round Rock, Texas, United States, 78681
        • Central Texas Neurology Consultants
        • Contact:
          • Phone Number: 512-218-1222
        • Principal Investigator:
          • Elizabeth Peckham
      • San Antonio, Texas, United States, 78229
        • The University of Texas Health Science Center
        • Principal Investigator:
          • Sudha Seshadri
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Re:Cognition Health
        • Principal Investigator:
          • Raymond Turner
        • Contact:
          • Phone Number: 703-520-9703
    • Washington
      • Kirkland, Washington, United States, 98034
        • EvergreenHealth
        • Contact:
          • Phone Number: 425-899-5385
        • Principal Investigator:
          • Pinky Agarwal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo administered IV
Drug: Placebo
Placebo administered IV
Experimental: Donanemab (LY3002813)
Donanemab (LY3002813) administered as an intravenous (IV) infusion
Drug: Donanemab
Donanemab administered IV
Other Names:
  • LY3002813

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Time Frame: Baseline through Week 52
Baseline through Week 52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from Baseline for Integrated Alzheimer's Disease Rating Scale (iADRS)
Time Frame: Baseline through Week 52
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
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
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
Baseline through Week 52
Change from Baseline in Brain Amyloid Plaque Levels
Time Frame: Baseline through Week 52
Baseline through Week 52
Trough Concentration at Steady State
Time Frame: Baseline through Week 52
Baseline through Week 52
Maximum Concentration at Steady State
Time Frame: Baseline through Week 52
Baseline through Week 52
Antidrug Antibodies (ADA) Against Donanemab
Time Frame: Baseline through Week 52
Baseline through Week 52
Frequency of Neutralizing Antibodies to Donanemab Treatment-Emergent ADA-Positive Participants
Time Frame: Baseline through Week 52
Baseline through Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 11, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 27790
  • I5T-MC-AACV (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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