Solanezumab Safety Study in Japanese Patients With Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00749216
First received: September 5, 2008
Last updated: May 27, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: Solanezumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multiple-Dose Safety in Japanese Subjects With Mild-to-Moderate Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in the extended ADAS-Cog stand for Alzheimer's Disease Assessment Scale-Cognitive subscale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • pharmacodynamic of Aβ1-40 and Aβ1-42 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: QW
IV infusion of 400mg once each week for 2 months
Drug: Solanezumab
Other Name: LY2062430
Experimental: Q4W
IV infusion of 400mg once every four weeks for 2 months
Drug: Solanezumab
Other Name: LY2062430
Experimental: Q8W
IV infusion of 400mg once every eight weeks for 2 months
Drug: Solanezumab
Other Name: LY2062430

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00749216

Locations
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.
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
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
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00749216     History of Changes
Other Study ID Numbers: 12025, H8A-JE-LZAK
Study First Received: September 5, 2008
Last Updated: May 27, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014