A Study of LY3303560 in Participants With Mild Cognitive Impairment or Alzheimer's Disease

NCT ID: NCT03019536

Last Updated: 2023-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2019-06-05

Brief Summary

The study involves repeated doses of LY3303560 given by infusion for 49 weeks. The study will examine how safe repeated doses of LY3303560 are, whether they cause side effects in participants with mild cognitive impairment or Alzheimer's Disease, and how LY3303560 is handled by the body and acts in the body. This study will last up to 65 weeks, not including screening. Screening is required within 90 days prior to the start of the study.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

70 mg LY3303560

70 milligram (mg) LY3303560 administered intravenously (IV) every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses), followed by a 16-week follow-up period.

Group Type: EXPERIMENTAL

LY3303560 - IV

Intervention Type: DRUG

Administered IV

Placebo - IV

Intervention Type: DRUG

Administered IV

Florbetapir F 18

Intervention Type: DRUG

Administered IV during the Positron Emission Tomography (PET) scan performed during screening.

Flortaucipir F18

Intervention Type: DRUG

Administered IV during the PET scan performed during the study.

210 mg LY3303560

210 mg LY3303560 administered IV every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses), followed by a 16-week follow-up period.

Group Type: EXPERIMENTAL

LY3303560 - IV

Intervention Type: DRUG

Administered IV

Placebo - IV

Intervention Type: DRUG

Administered IV

Florbetapir F 18

Intervention Type: DRUG

Administered IV during the Positron Emission Tomography (PET) scan performed during screening.

Flortaucipir F18

Intervention Type: DRUG

Administered IV during the PET scan performed during the study.

Placebo IV

Placebo administered intravenously (IV) every 4 weeks for 25 weeks with the option of continuing treatment up to 49 weeks (up to 6 further doses),, followed by a 16-week follow-up period.

Group Type: EXPERIMENTAL

Placebo - IV

Intervention Type: DRUG

Administered IV

Florbetapir F 18

Intervention Type: DRUG

Administered IV during the Positron Emission Tomography (PET) scan performed during screening.

Flortaucipir F18

Intervention Type: DRUG

Administered IV during the PET scan performed during the study.

Interventions

LY3303560 - IV

Administered IV

Intervention Type: DRUG

Placebo - IV

Administered IV

Intervention Type: DRUG

Florbetapir F 18

Administered IV during the Positron Emission Tomography (PET) scan performed during screening.

Intervention Type: DRUG

Flortaucipir F18

Administered IV during the PET scan performed during the study.

Intervention Type: DRUG

Other Intervention Names

AV-1451; [F-18]T807; LY3191748

Eligibility Criteria

Inclusion Criteria

• Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild-to-moderate AD based on National Institute of Aging and Alzheimer's Association diagnostic criteria
• Female participants: women not of child-bearing potential may participate, and include those who are:

• Infertile due to surgical sterilisation (hysterectomy, bilateral oophorectomy, or for countries outside of Japan, tubal ligation), congenital anomaly such as mullerian agenesis; or
• Postmenopausal defined as women at least 50 years of age with an intact uterus who have not taken hormones or oral contraceptives within 1 year, who have had either cessation of menses for at least 1 year, or 6 to 12 months of spontaneous amenorrhea with follicle-stimulating greater than (>) 40 milli-international units per millilitre (mIU/mL)
• Have a body weight of at least 50 kilogram (kg) (except for Japanese sites) and have a body mass index (BMI) of 18.0 to 35.0 kilogram per meter square (kg/m²) (for all sites), inclusive, at screening

Exclusion Criteria

• Are currently enrolled in a clinical trial involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
• Have participated, within the last 30 days (3 months and 4 months for sites in the European Union [EU] and Japan, respectively) in a clinical trial involving an IP. If the previous IP has a long half-life, 3 months (4 months for sites in Japan) or 5 half-lives (whichever is longer) should have passed
• Have known allergies to LY3303560, related compounds or any components of the formulation, or history of significant atopy
• Have significant allergies to humanised monoclonal antibodies, diphenhydramine, adrenaline, or methylprednisolone; or have a history of clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
• Have an increased risk of seizures as evidenced by a history of head trauma with loss of consciousness within the last 5 years or any seizure; prior electroencephalogram with epileptiform activity; surgery to the cerebral cortex; or history within the last 5 years of a serious infectious disease affecting the brain
• Have any contraindications for Magnetic Resonance Imaging (MRI) studies, including claustrophobia, or the presence of metal (ferromagnetic) implants or a cardiac pacemaker
• Have a history of intracranial haemorrhage, cerebrovascular aneurysm, or arteriovenous malformation, carotid artery occlusion, or epilepsy
• Have received acetylcholinesterase inhibitors (AChEIs), memantine, and/or other AD therapy for less than 4 weeks, or have less than 4 weeks of stable therapy on these treatments by time of randomisation (including less than 4 weeks since stopping AChEIs and/or memantine); or have received medications that affect the central nervous system, except treatments for AD, for less than 4 weeks at a stable dose
• Have used stable medical therapy for less than 2 months by time of randomization for any concurrent medical condition that is not exclusionary
• Are currently using or intend to use drugs known to significantly prolong the QT interval, or who have a known risk factor for Torsades de Pointes. A participant will not be excluded if they have been using stable medication that is known to potentially cause significant prolongation of the QT interval, but does not present with any clinically significant prolongation of the QT interval at screening, in the opinion of the investigator
• History of cancer within the last 5 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer, or other cancers with low risk of recurrence or spread.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Eli Lilly and Company

Locations

Bioclinica

Melbourne, Florida, United States

Bioclinica

Orlando, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Bioclinica

The Villages, Florida, United States

Princeton Medical Institute

Princeton, New Jersey, United States

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

Bunkyō City, , Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Hyōgo, , Japan

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

Kurume, , Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tokyo, , Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Bath, , United Kingdom

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

London, , United Kingdom

Countries

United States; Japan; United Kingdom

References

Willis BA, Lo AC, Dage JL, Shcherbinin S, Chinchen L, Andersen SW, LaBell ES, Perahia DGS, Hauck PM, Lowe SL. Safety, Tolerability, and Pharmacokinetics of Zagotenemab in Participants with Symptomatic Alzheimer's Disease: A Phase I Clinical Trial. J Alzheimers Dis Rep. 2023 Sep 15;7(1):1015-1024. doi: 10.3233/ADR-230012. eCollection 2023.

Reference Type: DERIVED

PMID: 37849628 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://trials.lilly.com/en-US/trial/122040

Click here for more information about this study: A Study of LY3303560 in Participants With Mild Cognitive Impairment or Alzheimer's Disease

Other Identifiers

I8G-MC-LMDD

Identifier Type: OTHER

Identifier Source: secondary_id

2016-002102-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

16452

Identifier Type: -

Identifier Source: org_study_id