Progress of Mild Alzheimer’s Disease in Patients on Solanezumab versus Placebo

• Register: EUCTR
• Last refreshed on: 3 April 2017
• Main ID: EUCTR2013-001119-54-GB
• Date of registration: 31/05/2013
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• 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: 27/09/2013
• 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
• Affiliation: Eli Lilly

• Name: Clinical Trial Information
• 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: 18.1 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)

Secondary Objective: • To test the hypothesis that solanezumab will slow the functional
decline of AD as compared with placebo in patients with mild AD
• 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 AD assessed using a slope analysis from a repeated-measures model.

Primary end point(s): ADAS-Cog14

Timepoint(s) of evaluation of this end point: Week 0, 12, 28, 40, 52, 64, 80 and Early Discontinuation Visits

Main Objective: To test the hypothesis that solanezumabwill slow the cognitive decline of AD as compared with placebo in patients with mild AD.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Week 0, 28, 52, 80 and Early Discontinuation Visits

Secondary end point(s): ADAS-Cog11, MMSE, ADCS-ADL, FAQ, CDR-SB, NPI, RUD-Lite, QoL-AD, EQ-5D Proxy, ADCS-iADL and the iADRS .

Secondary ID(s)

H8A-MC-LZAX

Source(s) of Monetary Support

Eli Lilly and Company