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Trial record 10 of 11 for:    LY2062430

A Study of LY2599666 in Healthy Participants and Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD)

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ClinicalTrials.gov Identifier: NCT02614131
Recruitment Status : Terminated (New data suggests that insufficient target engagement would be achieved for efficacy.)
First Posted : November 25, 2015
Last Update Posted : January 10, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY2599666 in different groups of people - those who are healthy, those who have mild cognitive impairment due to Alzheimer's Disease (AD), and those with mild-to-moderate AD. The study will measure how much LY2599666 gets into the bloodstream and how long it takes the body to get rid of it. It will also evaluate how LY2599666 affects the body. The study has three parts. Part A will last about 2 months. Parts B and C will each last about 23 weeks. Participants may only enroll in one part.

Condition or disease Intervention/treatment Phase
Healthy Alzheimer's Disease Mild Cognitive Impairment Drug: LY2599666 Drug: Solanezumab Drug: Placebo SC Drug: Placebo IV Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Single-Dose and Multiple-Dose, Dose-Escalation Study With LY2599666 to Evaluate the Safety, Pharmacokinetics, and Tolerability in Healthy Subjects and Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild-to-Moderate Alzheimer's Disease
Study Start Date : December 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY2599666 (Part A)
LY2599666 given subcutaneously (SC) once.
Drug: LY2599666
Administered SC

Placebo Comparator: Placebo (Part A)
Placebo matching LY2599666 given SC once.
Drug: Placebo SC
Administered SC

Experimental: LY2599666 (Part B)
LY2599666 given SC once weekly for 12 weeks (13 doses).
Drug: LY2599666
Administered SC

Placebo Comparator: Placebo (Part B)
Placebo given SC once weekly for 12 weeks (13 doses).
Drug: Placebo SC
Administered SC

Experimental: Solanezumab (Part C)
Solanezumab given intravenously (IV) once weekly or once every 4 weeks for 12 weeks.
Drug: Solanezumab
Administered IV
Other Name: LY2062430

Placebo Comparator: Placebo (Part C)
Placebo given IV once weekly or once every 4 weeks for 12 weeks.
Drug: Placebo IV
Administered IV




Primary Outcome Measures :
  1. Number of Participants With One or More Serious Adverse Event (SAE) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through 4 weeks (Part A) or 16 weeks (Parts B and C) ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2599666 and Solanezumab [ Time Frame: Predose day 1 through day 29 (Part A) or Predose day 85 through day 113 (Parts B and C) ]
  2. Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY2599666 and Solanezumab [ Time Frame: Predose day 1 through day 29 (Part A) or Predose day 85 through day 113 (Parts B and C) ]
  3. Plasma Amyloid Beta (Abeta) Concentration [ Time Frame: Predose day 1 through day 29 (Part A) or Predose day 85 through day 113 (Parts B and C) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy Participants Part A:

  • Overtly healthy males or females as determined by medical history and physical examination
  • Have a body mass index (BMI) between 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive

Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part B and C]:

  • Participants are at least 50 years old at screening
  • Present with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or mild-to-moderate AD
  • Have a caregiver/study informant who provides a separate written informed consent to participate
  • Have adequate vision and hearing for neuropsychological testing in the opinion of the investigator
  • Positive florbetapir scan

Exclusion Criteria:

All Participants

  • Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have known allergies to LY2599666, solanezumab, or any related compounds or components of the formulations, or have a history of significant atopy
  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study
  • Have an abnormal blood pressure as determined by the investigator
  • Have significant allergies to humanized monoclonal antibodies, diphenhydramine, epinephrine, or methylprednisone
  • Require treatment with other monoclonal antibodies

Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part B and C]

  • Have medical or surgical conditions in which lumbar puncture and or/catheter insertion is contraindicated
  • Have any contraindication for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI

Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part C]

  • Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate-specific antigen post treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614131


Locations
United States, California
Parexel Early Phase Unit at Glendale
Glendale, California, United States, 91206
United States, New Jersey
CRI Lifetree
Marlton,, New Jersey, United States, 08053
United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84106
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.
Kobe, Japan, 650-0047
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.
Shinjuku-Ku, Japan, 169-0073
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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) Eli Lilly and Company

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02614131     History of Changes
Other Study ID Numbers: 15491
I2L-MC-ALCA ( Other Identifier: Eli Lilly and Company )
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders