Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
EUCTR |
Last refreshed on:
|
3 April 2017 |
Main ID: |
EUCTR2013-001119-54-ES |
Date of registration:
|
14/08/2013 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
Progress of Mild Alzheimer?s Disease in Patients on Solanezumab versus Placebo
|
Scientific title:
|
Effect of Passive Immunization on the Progression of Mild Alzheimer?s Disease: Solanezumab (LY2062430) versus Placebo - EXPEDITION 3 |
Date of first enrolment:
|
28/10/2013 |
Target sample size:
|
2100 |
Recruitment status: |
Not Recruiting |
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001119-54 |
Study type:
|
Interventional clinical trial of medicinal product |
Study design:
|
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
|
Phase:
|
Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
|
|
Countries of recruitment
|
France
|
Germany
|
Italy
|
Poland
|
Spain
|
Sweden
|
United Kingdom
| |
Contacts
|
Name:
|
Clinical Trial Information
|
Address:
|
Lilly Corporate Center
IN 46285
Indianapolis
United States |
Telephone:
|
|
Email:
|
EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
|
Eli Lilly |
|
Name:
|
Clinical Trial Information
|
Address:
|
Lilly Corporate Center
IN 46285
Indianapolis
United States |
Telephone:
|
|
Email:
|
EU_Lilly_Clinical_Trials@lilly.com |
Affiliation:
|
Eli Lilly |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria: [1] Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer?s Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD. [2] Has a Modified Hachinski Ischemia Scale score of less than or equal to 4. [3] Has an MMSE score of 20 through 26 at Visit 1 (Screening visit). [4] Has a Geriatric Depression Scale score of less than or equal to 6 (on the staff-administered short form). [5] Has had an MRI or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD. [6] Male or female patients ages 55 to 90 years old. [7] Has a florbetapir PET scan or CSF result consistent with the presence of amyloid pathology at screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 420 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1680
Exclusion criteria: [1] Does not have a reliable caregiver who is in frequent contact with the patient (defined as at least 10 hours per week), will accompany the patient to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications. [2] Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l?Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia. [3] Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator?s opinion, could interfere with the analyses of safety and efficacy in this study; or has a life expectancy of <2 years. [4] Has had a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness. [5] Has 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 prostate-specific antigen posttreatment. [6] Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions [7] Has received AChEIs, memantine and/or other AD therapy for less than 4 months or has less than 2 months of stable therapy on these treatments [8] Has received medications that affect the central nervous system (CNS), except treatments for AD for less than 4 weeks.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
|
Health Condition(s) or Problem(s) studied
|
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
|
Mild Alzheimer's Disease MedDRA version: 16.0
Level: LLT
Classification code 10001896
Term: Alzheimer's disease
System Organ Class: 100000004852
|
Intervention(s)
|
Product Name: Solanezumab Product Code: LY2062430 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Solanezumab Current Sponsor code: LY2062430 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use
|
Primary Outcome(s)
|
Main Objective: To test the hypothesis that solanezumabwill slow the cognitive and functional decline of AD as compared with placebo in patients with mild AD.
|
Primary end point(s): ADAS-Cog14 and ADCS-iADL
|
Secondary Objective: ? To assess the relationship between treatment effect and time. ? To test the hypothesis that solanezumab will slow the rate of cognitive and functional decline associated with ADassessed using a slope analysis from a repeated-measures model.
|
Timepoint(s) of evaluation of this end point: Week 0, 12, 28, 40, 52, 64, 80 and Early Discontinuation Visits
|
Secondary Outcome(s)
|
Secondary end point(s): ADAS-Cog11, MMSE, ADCS-ADL, FAQ, CDR-SB, NPI, RUD-Lite, QoL-AD, and EQ-5D Proxy.
|
Timepoint(s) of evaluation of this end point: Week 0, 28, 52, 80 and Early Discontinuation Visits
|
Secondary ID(s)
|
H8A-MC-LZAX
|
2013-001119-54-GB
|
Source(s) of Monetary Support
|
Eli Lilly and Company
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|