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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02008357




Registration number
NCT02008357
Ethics application status
Date submitted
6/12/2013
Date registered
11/12/2013
Date last updated
28/12/2023

Titles & IDs
Public title
Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss
Scientific title
Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)
Secondary ID [1] 0 0
H8A-MC-LZAZ
Secondary ID [2] 0 0
15275
Universal Trial Number (UTN)
Trial acronym
A4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognition Disorders 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Learning disabilities
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - Solanezumab

Experimental: Solanezumab/Solanezumab - Participants received 400 milligram (mg) solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered intravenously (IV) every 4 weeks (Q4W) for approximately 240 weeks in double-blind placebo-controlled period.
Participants begin open label extension and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).

Placebo Comparator: Placebo/Solanezumab - Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind period.
Participants begin open label extension period and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).


Treatment: Drugs: Placebo
Administered IV

Treatment: Drugs: Solanezumab
Administered IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score
Timepoint [1] 0 0
Baseline, Week approximately 240
Primary outcome [2] 0 0
Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score
Timepoint [2] 0 0
Baseline, Week 336
Secondary outcome [1] 0 0
Change From Baseline in Cognitive Function Index (CFI)
Timepoint [1] 0 0
Baseline, Week approximately 240
Secondary outcome [2] 0 0
Change From Baseline in Cognitive Function Index (CFI)
Timepoint [2] 0 0
Baseline, Week 336
Secondary outcome [3] 0 0
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score
Timepoint [3] 0 0
Baseline, Week approximately 240
Secondary outcome [4] 0 0
Change From Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score
Timepoint [4] 0 0
Baseline, Week 336
Secondary outcome [5] 0 0
Change From Baseline in Mean Composite Standardized Uptake Value Ratio (SUVr)
Timepoint [5] 0 0
Baseline, Week approximately 240
Secondary outcome [6] 0 0
Change From Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers
Timepoint [6] 0 0
Baseline, Week approximately 240
Secondary outcome [7] 0 0
Change From Baseline of Cerebrospinal Fluid (CSF) Concentrations of Amyloid Beta (Aß)
Timepoint [7] 0 0
Baseline, Week approximately 240
Secondary outcome [8] 0 0
Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)
Timepoint [8] 0 0
Baseline, Week approximately 240
Secondary outcome [9] 0 0
Change From Baseline on the Clinical Dementia Rating-Sum of Boxes Score (CDR-SB)
Timepoint [9] 0 0
Baseline, Week 336
Secondary outcome [10] 0 0
Change From Baseline on the Computerized Cognitive Composite (C3)
Timepoint [10] 0 0
Baseline, Week 336

Eligibility
Key inclusion criteria
- Has a Mini-Mental State Examination (MMSE) score at screening of 25 to 30

- Has a global Clinical Dementia Rating (CDR) scale score at screening of 0

- Has a Logical Memory II score at screening of 6 to 18

- Has a florbetapir positron emission tomography (PET) scan that shows evidence of brain
amyloid pathology at screening

- Has a study partner that is willing to participate as a source of information and has
at least weekly contact with the participant (contact can be in-person, via telephone
or electronic communication)
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at
screening or baseline

- Lacks good venous access, such that intravenous drug delivery or multiple blood draws
would be precluded

- Has current serious or unstable illness including cardiovascular, hepatic, renal,
gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic,
or hematologic disease or other conditions that, in the investigator's opinion, could
interfere with the analyses of safety and efficacy in this study

- Has had 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

- Has had a history within the last 5 years of a primary or recurrent malignant disease
with the exception of any in situ cancer that was appropriately treated and is being
appropriately monitored, such as resected cutaneous squamous cell carcinoma in situ or
in situ prostate cancer with normal prostate-specific antigen post-treatment

- Has a known history of human immunodeficiency virus (HIV), clinically significant
multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions
(including, but not limited to, erythema multiforme major, linear immunoglobulin A
dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)

- Is clinically judged by the investigator to be at serious risk for suicide

- Has a history within the past 2 years of major depression or bipolar disorder as
defined by the most current version of the Diagnostic and Statistical Manual of Mental
Disorders (DSM)

- Has a history within the past 5 years of chronic alcohol or drug abuse/dependence as
defined by the most current version of the DSM

Open-Label Inclusion Criteria:

- All participants who complete the placebo-controlled period will be allowed to
continue into the open-label period

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/06/2023
Sample size
Target
Accrual to date
Final
1169
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
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. - Parkville
Recruitment postcode(s) [1] 0 0
3010 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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Connecticut
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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Nevada
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Texas
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Washington
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Wisconsin
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Canada
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London
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Canada
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Toronto
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Canada
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Vancouver
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Japan
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Bunkyo-ku

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Alzheimer's Therapeutic Research Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to test whether an investigational drug called solanezumab can
slow the progression of memory problems associated with brain amyloid (protein that forms
plaques in the brains of people with Alzheimer Disease [AD]).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02008357
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries