- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00749216
Solanezumab Safety Study in Japanese Patients With Alzheimer's Disease
May 27, 2010 updated by: Eli Lilly and Company
Multiple-Dose Safety in Japanese Subjects With Mild-to-Moderate Alzheimer's Disease
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple dosing Solanezumab in subjects with mild-to-moderate AD in Japanese population.
Study Overview
Study Type
Interventional
Enrollment (Actual)
33
Phase
- 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 Locations
-
-
-
Ehime, Japan, 791-0295
- 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.
-
Hiroshima, Japan, 728-0001
- 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.
-
Hyogo, Japan, 672-8501
- 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.
-
Kyoto, Japan, 616-8255
- 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.
-
Osaka, Japan, 530
- 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.
-
Tokushima, Japan, 770-8503
- 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.
-
-
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
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men or non-fertile women, at least 50 years of age.(Women who are not surgically sterilized must be post-menopausal for at least 1 year.)
Patients with mild to moderate AD by following disease diagnostic criteria
- National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
- Modified Hachinski Ischemia Scale score of ≦ 4
- Folstein Mini-Mental State Examination (MMSE) score of 15 through 26
- Geriatric Depression Scale (GDS) score of ≦ 10 on the staff-administered short form
Exclusion Criteria:
- Patients who don't have a reliable caregiver who is in frequent contact with the patient, who will accompany the patient to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications.
- Patients who have an MRI or CT scan since the onset of symptoms of AD that is inconsistent with a diagnosis of AD.
- Patients who have received acetylcholinesterase inhibitors (AChEIs) or memantine for less than 4 months, or have less than 2 months of stable therapy on these treatments.
- Patients who have current serious or unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator or subinvestigator(s)'s opinion, could interfere with the analyses of safety and efficacy in this study.
- Patients who have a history within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma resulting in protracted loss of consciousness within the last 5 years, or multiple episodes of head trauma.
- Patients who have a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal PSA post-resection.
- Patients who have allergies to humanized monoclonal antibodies.
- Patients who have a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal PSA post-resection.
- Patients who have ECG abnormalities obtained that, in the opinion of the investigator, are clinically significant with regard to the subject's participation in the study, including QTc prolongation (Bazett's corrected QTc interval, QTcB; males >435 msec or females >455 msec) or abnormally wide QRS complexes (resulting from bundle-branch blocks, interventricular conduction delays, or pacemakers).
- Patients who have a current, required use or expected use of excluded drugs through the duration(These drugs include typical neuroleptics (antipsychotics). In addition, typical neuroleptics may not be taken within 4 weeks.
- Patients who are currently taking chronic medications that affect central nervous system (CNS) function, and are not dose-stabilized for at least 4 weeks.
- Patients who have a ventriculoperitoneal shunt or gamma globulin (IgG) therapy within the last year.
- Patients who have previously completed or withdrawn from this study or previous participation in any other study investigating active immunization against Aβ.
- Patients who have any contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker.
- Patients who weigh less than 40 kg.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: QW
IV infusion of 400mg once each week for 2 months
|
Other Names:
|
Experimental: Q4W
IV infusion of 400mg once every four weeks for 2 months
|
Other Names:
|
Experimental: Q8W
IV infusion of 400mg once every eight weeks for 2 months
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics
Time Frame: 6 months
|
6 months
|
Changes in the extended ADAS-Cog stand for Alzheimer's Disease Assessment Scale-Cognitive subscale
Time Frame: 6 months
|
6 months
|
pharmacodynamic of Aβ1-40 and Aβ1-42
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 1, 2008
Primary Completion (Actual)
July 1, 2009
Study Completion (Actual)
July 1, 2009
Study Registration Dates
First Submitted
September 5, 2008
First Submitted That Met QC Criteria
September 5, 2008
First Posted (Estimate)
September 9, 2008
Study Record Updates
Last Update Posted (Estimate)
June 2, 2010
Last Update Submitted That Met QC Criteria
May 27, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12025 (Other Identifier: DAIDS-ES ID)
- H8A-JE-LZAK (Other Identifier: Eli Lilly and Company)
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.
Clinical Trials on Alzheimer's Disease
-
University of Southern CaliforniaAlzheimer's Therapeutic Research Institute; American Heart Association; Schaeffer...RecruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
-
University of Southern CaliforniaNational Institute on Aging (NIA); Alzheimer's Therapeutic Research Institute; Brigham and Women's Hospital and other collaboratorsActive, not recruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
-
University Hospital, BordeauxMinistry for Health and Solidarity, FranceCompletedAlzheimer's Disease (AD) | Alzheimer's Disease (AD) Related DisordersFrance
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease | Normal CognitionUnited States
-
University of Colorado, DenverNational Institute on Aging (NIA)Active, not recruitingSuspected Typical Alzheimer's Disease (AD) | Suspected Atypical Alzheimer's Disease (AD)United States
Clinical Trials on Solanezumab
-
Eli Lilly and CompanyAlzheimer's Therapeutic Research InstituteCompletedCognition DisordersUnited States, Canada, Australia, Japan
-
Eli Lilly and CompanyTerminatedHealthy | Mild Cognitive Impairment | Alzheimer's DiseaseUnited States, Japan
-
Eli Lilly and CompanyTerminatedAlzheimer's DiseaseUnited States, Argentina, France, Japan, Canada, Korea, Republic of, Australia, Brazil, Spain, Taiwan, Italy, Poland, Germany, Russian Federation, United Kingdom, Sweden
-
Eli Lilly and CompanyTerminatedAlzheimer's DiseaseItaly, United States, Spain, Taiwan, France, Japan, Puerto Rico, Poland, Sweden, Finland, Canada, United Kingdom, Germany
-
Washington University School of MedicineEli Lilly and Company; Hoffmann-La Roche; Avid Radiopharmaceuticals; National Institute... and other collaboratorsCompletedDementia | Alzheimers Disease | Alzheimers Disease, FamilialUnited States, Canada, France, Spain, Ireland, Australia, Puerto Rico, United Kingdom
-
Eli Lilly and CompanyCompletedAlzheimer's DiseaseUnited States
-
Eli Lilly and CompanyTerminatedAlzheimer's DiseaseUnited States, Italy, France, Japan, Australia, Germany, Spain, Sweden, Canada, Poland, United Kingdom
-
Washington University School of MedicineEli Lilly and Company; Hoffmann-La Roche; Avid Radiopharmaceuticals; National Institute... and other collaboratorsRecruitingDementia | Alzheimers Disease | Alzheimers Disease, FamilialUnited States, Canada, Italy, Argentina, Australia, Brazil, Colombia, France, Germany, Ireland, Japan, Mexico, Netherlands, Puerto Rico, Spain, United Kingdom
-
Eli Lilly and CompanyCompletedAlzheimer's DiseaseUnited States, Argentina, Brazil, Japan, Canada
-
Eli Lilly and CompanyCompletedAlzheimer's DiseaseSpain, United States, France, Korea, Republic of, Japan, Australia, Taiwan, Sweden, Germany, Italy, Poland, Russian Federation, United Kingdom