NCT00749216

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

June 2, 2010

Status Verified

May 1, 2010

Enrollment Period

10 months

First QC Date

September 5, 2008

Last Update Submit

May 27, 2010

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Adverse events

    6 months

Secondary Outcomes (3)

  • Changes in the extended ADAS-Cog stand for Alzheimer's Disease Assessment Scale-Cognitive subscale

    6 months

  • pharmacodynamic of Aβ1-40 and Aβ1-42

    6 months

  • Pharmacokinetics

    6 months

Study Arms (3)

QW

EXPERIMENTAL

IV infusion of 400mg once each week for 2 months

Drug: Solanezumab

Q4W

EXPERIMENTAL

IV infusion of 400mg once every four weeks for 2 months

Drug: Solanezumab

Q8W

EXPERIMENTAL

IV infusion of 400mg once every eight weeks for 2 months

Drug: Solanezumab

Interventions

SolanezumabDRUG
Also known as: LY2062430
Q4WQ8WQW

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

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, 791-0295, Japan

Location

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, 728-0001, Japan

Location

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, 672-8501, Japan

Location

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, 616-8255, Japan

Location

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, 530, Japan

Location

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, 770-8503, Japan

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Interventions

solanezumab

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 5, 2008

First Posted

September 9, 2008

Study Start

September 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

June 2, 2010

Record last verified: 2010-05

Locations

JP(6)