Trial Outcomes & Findings for A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease (NCT NCT02760602)
NCT ID: NCT02760602
Last Updated: 2019-10-10
Results Overview
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.
TERMINATED
PHASE3
26 participants
Baseline, 24 Months
2019-10-10
Participant Flow
Participants were randomized by site and by use of florbetapir positron emission tomography (PET) scanning or cerebrospinal fluid (CSF) for study eligibility.
Participant milestones
| Measure |
Solanezumab
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
|
Placebo
Placebo given IV once every 4 weeks for up to 2 years.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
13
|
Reasons for withdrawal
| Measure |
Solanezumab
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
|
Placebo
Placebo given IV once every 4 weeks for up to 2 years.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Terminated by sponsor
|
12
|
13
|
Baseline Characteristics
A Study of Solanezumab (LY2062430) in Participants With Prodromal Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Solanezumab
n=13 Participants
Solanezumab given IV once every 4 weeks for up to 2 years.
|
Placebo
n=13 Participants
Placebo given IV once every 4 weeks for up to 2 years.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
73.46 years
STANDARD_DEVIATION 6.01 • n=93 Participants
|
75.62 years
STANDARD_DEVIATION 4.93 • n=4 Participants
|
74.54 years
STANDARD_DEVIATION 5.49 • n=27 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Region of Enrollment
Japan
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
ADAS-Cog14 at Baseline
|
24.08 units on a scale
STANDARD_DEVIATION 8.00 • n=93 Participants
|
27.77 units on a scale
STANDARD_DEVIATION 3.63 • n=4 Participants
|
25.92 units on a scale
STANDARD_DEVIATION 6.37 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
RBANS is a brief neurocognitive battery with four alternate forms, measuring immediate and delayed memory, attention, language, and visuospatial/constructional skills.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
Concentration of amino acid peptide known as Aβ 1-42 in plasma.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
MRI will be used to assess the effect of treatment on rate of whole brain volume.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
Changes in CSF parameters, including total and free Aβ1-40 and Aβ1-42 species and total tau and P-tau181 peptides, will be assessed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 24 MonthsPopulation: Zero participants were analyzed as no data collected.
Biomarker change will be analyzed to provide biomarker-based evidence that solanezumab affects the underlying disease pathology.
Outcome measures
Outcome data not reported
Adverse Events
Solanezumab
Placebo
Serious adverse events
| Measure |
Solanezumab
n=13 participants at risk
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
|
Placebo
n=13 participants at risk
Placebo given IV once every 4 weeks for up to 2 years.
|
|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
7.7%
1/13 • Number of events 1 • Baseline to Study Termination (Up To 11 Months)
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
7.7%
1/13 • Number of events 1 • Baseline to Study Termination (Up To 11 Months)
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Number of events 1 • Baseline to Study Termination (Up To 11 Months)
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
Other adverse events
| Measure |
Solanezumab
n=13 participants at risk
Solanezumab given intravenously (IV) once every 4 weeks for up to 2 years.
|
Placebo
n=13 participants at risk
Placebo given IV once every 4 weeks for up to 2 years.
|
|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
7.7%
1/13 • Number of events 2 • Baseline to Study Termination (Up To 11 Months)
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
|
Gastrointestinal disorders
Constipation
|
7.7%
1/13 • Number of events 1 • Baseline to Study Termination (Up To 11 Months)
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
|
General disorders
Extravasation
|
7.7%
1/13 • Number of events 2 • Baseline to Study Termination (Up To 11 Months)
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
|
Infections and infestations
Upper respiratory tract infection
|
15.4%
2/13 • Number of events 2 • Baseline to Study Termination (Up To 11 Months)
|
7.7%
1/13 • Number of events 1 • Baseline to Study Termination (Up To 11 Months)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.7%
1/13 • Number of events 1 • Baseline to Study Termination (Up To 11 Months)
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13 • Number of events 1 • Baseline to Study Termination (Up To 11 Months)
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
7.7%
1/13 • Number of events 4 • Baseline to Study Termination (Up To 11 Months)
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
7.7%
1/13 • Number of events 1 • Baseline to Study Termination (Up To 11 Months)
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • Baseline to Study Termination (Up To 11 Months)
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
7.7%
1/13 • Number of events 1 • Baseline to Study Termination (Up To 11 Months)
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
7.7%
1/13 • Number of events 1 • Baseline to Study Termination (Up To 11 Months)
|
|
Surgical and medical procedures
Endodontic procedure
|
7.7%
1/13 • Number of events 1 • Baseline to Study Termination (Up To 11 Months)
|
0.00%
0/13 • Baseline to Study Termination (Up To 11 Months)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER