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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD

NCT02624778

Alzheimer Disease

COMPLETED PHASE1

A Study of LY3202626 on Disease Progression in Participants With Mild Alzheimer's Disease Dementia

NCT02791191

Alzheimer's Disease

TERMINATED PHASE2

A Study of LY3202626 in Healthy Participants and Participants With Alzheimer's Disease

NCT02323334

Healthy Volunteers Alzheimer Disease

COMPLETED PHASE1

A Study of LY3303560 in Healthy Participants and Participants With Alzheimer's Disease (AD)

NCT02754830

Alzheimer's Disease

COMPLETED PHASE1

Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo

NCT01900665

Alzheimer's Disease

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Alzheimer's Disease Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LY2599666 (Part A)

LY2599666 given subcutaneously (SC) once.

Group Type EXPERIMENTAL

LY2599666

Intervention Type DRUG

Administered SC

Placebo (Part A)

Placebo matching LY2599666 given SC once.

Group Type PLACEBO_COMPARATOR

Placebo SC

Intervention Type DRUG

Administered SC

LY2599666 (Part B)

LY2599666 given SC once weekly for 12 weeks (13 doses).

Group Type EXPERIMENTAL

LY2599666

Intervention Type DRUG

Administered SC

Placebo (Part B)

Placebo given SC once weekly for 12 weeks (13 doses).

Group Type PLACEBO_COMPARATOR

Placebo SC

Intervention Type DRUG

Administered SC

Solanezumab (Part C)

Solanezumab given intravenously (IV) once weekly or once every 4 weeks for 12 weeks.

Group Type EXPERIMENTAL

Solanezumab

Intervention Type DRUG

Administered IV

Placebo (Part C)

Placebo given IV once weekly or once every 4 weeks for 12 weeks.

Group Type PLACEBO_COMPARATOR

Placebo IV

Intervention Type DRUG

Administered IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY2599666

Administered SC

Intervention Type DRUG

Solanezumab

Administered IV

Intervention Type DRUG

Placebo SC

Administered SC

Intervention Type DRUG

Placebo IV

Administered IV

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY2062430

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes