A Study of Solanezumab (LY2062430) in Participants With P... | NCT02760602

NCT02760602

ID	Type	Description	Link
H8A-MC-LZBE	Other Identifier	Eli Lilly and Company
2016-000108-27	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Solanezumab	Experimental	Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.	Drug: Solanezumab
Placebo	Experimental	Placebo given IV once every 4 weeks for up to 2 years.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Solanezumab	Drug	Administered IV	Solanezumab	LY2062430

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score	ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.	Baseline, 24 Months

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)	The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs. Total score ranges from 0 to 69; lower score indicates greater disease severity.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
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

Facility	Status	City	State	ZIP	Country	Contacts
Xenoscience		Phoenix	Arizona	85004	United States
Banner Alzheimer's Institute

References Module

Label	URL
Click here for more information about this study: A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

ID	Title	Description
FG000	Solanezumab	Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
FG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 28, 2016	May 2, 2018

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

All enrolled participants who received at least one dose of study drug.

Arm/Group Information

ID	Title	Description
BG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
BG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00073.46± 6.01 BG00175.62± 4.93 BG00274.54± 5.49

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0004 BG0016 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00010 BG00111 BG002

ADAS-Cog14 at Baseline

ADAS-Cog14 is ADAS-Cog11 augmented with orientation, verbal memory, language, praxis, delayed free recall, digit cancellation, and maze-completion measures. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater disease severity.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00024.08± 8.00 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline in Alzheimer´s Disease Assessment Scale- Cognitive Subscale (ADAS-Cog14) Score

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG0000 OG0010

Secondary

Change From Baseline on Alzheimer´s Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS-MCI-ADL)

The ADCS-MCI-ADL is a functional evaluation scale for MCI patients, based on information provided by an informant that describes the performance of participants in several ADLs. Total score ranges from 0 to 69; lower score indicates greater disease severity.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline on the Mini Mental Status Examination (MMSE)

MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, and copy figures) in elderly participants.Total score ranges from 0 to 30; lower score indicates greater disease severity.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline on the Montreal Cognitive Assessment (MoCA)

The MoCA will be used as the global cognitive screening instrument. It will also be administered in the clinical trial at baseline and the final visits of each phase as a secondary outcome measure of global cognition. Scores on the MoCA range from 0-30 with 26-30 indicating normal global cognition.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline on the Functional Activities Questionnaire (FAQ)

FAQ is a 10-item, caregiver-based questionnaire and was administered to the study partner who was asked to rate the participant's ability to perform a variety of activities ranging from Writing checks, Assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, Traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now = 1; Never did [the activity] but could do now = 0; Normal = 0; Has difficulty but does by self = 1; Requires assistance = 2; Dependent = 3). The maximum FAQ total score is 30, with higher scores indicating greater impairment.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants

Secondary

Change From Baseline on the Neuropsychiatric Inventory (NPI)

The NPI is a tool for assessing psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)

CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline on the Free and Cued Selective Reminding Test (FCSRT)

The FCSRT is a neuropsychological test of memory under conditions that control attention and cognitive processing in order to obtain an assessment of memory unconfounded by normal age-related changes in cognition.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline on the Resource Utilization in Dementia-Lite (RUD-Lite)

RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline on the EuroQol 5-Dimensional Health-Related Quality of Life Scale (EQ-5D)

EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Visual analogue scale (VAS) assesses caregiver's impression of participant's overall health state; scores range: 0 to 100. Lower scores indicate greater disease severity.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline on the Quality of Life in Alzheimer's Disease Scale (QoL-AD)

QoL for AD assess participant rates mood, relationships, memory, finances, physical condition, and overall QoL assessment. Each of 13 items rated on a 4-point scale. Sum of items=total score (range: 13-52). Higher scores=greater QoL.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Concentration of Plasma Amyloid-β Peptide (Aβ) and Plasma Solanezumab

Concentration of amino acid peptide known as Aβ 1-42 in plasma.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Volumetric Magnetic Resonance Imaging (vMRI)

MRI will be used to assess the effect of treatment on rate of whole brain volume.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)

Florbetapir F18 PET used to assess the treatment effect in brain amyloid plaque deposition from baseline through 18 months as measured by florbetapir F18 PET Standardized Uptake Uptake Value ratio.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Concentration of Cerebrospinal Fluid (CSF) Aβ and CSF Tau Proteins

Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Neocortical Tau Deposits Using 18F-AV-1451 PET

Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.

Zero participants were analyzed as no data collected.

Posted

Baseline, 24 Months

ID	Title	Description
OG000	Solanezumab	Solanezumab given IV once every 4 weeks for up to 2 years.
OG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Solanezumab	Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.	0	13	2	13	7	13
EG001	Placebo	Placebo given IV once every 4 weeks for up to 2 years.	0	13	1	13	1	13

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Pneumonia	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Syncope	Nervous system disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Coronary artery disease	Cardiac disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected13 at risk
Constipation	Gastrointestinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Extravasation	General disorders	MedDRA 20.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected13 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0011 events1 affected13 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 20.0	Systematic Assessment	EG0004 events1 affected13 at risk EG0010 events0 affected13 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Insomnia	Psychiatric disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 20.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected13 at risk
Endodontic procedure	Surgical and medical procedures	MedDRA 20.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected13 at risk

The study was terminated due to insufficient scientific evidence that solanezumab would likely demonstrate a meaningful benefit to pts with prodromal AD as defined by the study protocol. Zero pts were analyzed as no data collected for outcomes.

Certain Agreements

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders

ID	Term
C550616	solanezumab