Trial · NCT01127633
Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease
NCT01127633, Phase 3, Terminated, Eli Lilly and Company; results first posted 2018-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease. Trials, record NCT01127633. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01127633
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease
- NCT number
- NCT01127633
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,457 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Alzheimer's Disease
- Interventions
- Solanezumab, Placebo
- First posted
- 2010-05-21
- Last updated
- 2019-10-08
- Results first posted
- 2018-05-03
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Baseline through Week 104 | The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. |
| Secondary | Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14) | Baseline, Week 104 | ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean was determined by mixed model repeated measures (MMRM) methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 Mini-Mental State Examination (MMSE) status (mild/moderate), concomitant acetylcholinesterase inhibitors (AChEI)/Memantine use at baseline (yes/no), baseline age and treatment\*visit. |
| Secondary | Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) | Baseline, Week 104 | ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment\*visit. |
| Secondary | Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB) | Baseline, Week 104 | 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. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment\*visit. |
| Secondary | Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI) | Baseline, Week 104 | The NPI is a questionnaire administered to caregivers that quantifies behavioral changes in dementia. Each of the 12 behavioral domains the caregiver reports as present are scored for Frequency, scale: 1 (Occasionally) to 4 (Very Frequently), and Severity, scale: 1 (Mild) to 3 (Severe). If the domain is reported by the caregiver as 'Not Affected,' that domain is scored as 0. The individual domain scores are calculated by multiplying the frequency times the severity for each domain. NPI Total Score is calculated by adding the individual domain scores together for all 12 domains, with a scores range from 0 to 144. Lower scores indicated less severity and higher scores indicated a greater severity of neuropsychiatric disturbance. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment\*visit. |
| Secondary | Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours | Baseline, Week 104 | The RUD-Lite is a caregiver-completed assessment designed to assess the amount of formal and informal resources used by participants and the primary caregiver. It is completed by the caregiver and compiles data on the following resources: length of time the caregiver spends giving care, assisting participants with basic activities of daily living (BADL: eating dressing, grooming, bathing); assisting participants with instrumental activities of daily living (IADLs: shopping, cooking, housekeeping, laundry, transportation, taking medication, managing finances), and providing supervision. Scores range from 0 to 24 hours. Higher values indicate greater resource use. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment\*visit. |
| Secondary | Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) | Baseline, Week 104 | EQ-5D (proxy version) is a generic, multidimensional, health-related, quality-of-life instrument assessing caregiver's impression of participants overall health state. Profile allows caregivers to rate participant's health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood using a 3-level scale: 1 (no problem), 2 (some problems), and 3 (major problems). These attribute combinations are converted into a weighted Health-State Index Score according to the United States (US) population-based algorithm. EQ-5D US Population-Based Index Scores range from -0.11 to 1.0. A score of 1.0 indicated perfect health. The Overall Health State Index Score is caregiver-reported using a visual analogue scale marked 0 (worst imaginable health) to 100 (best imaginable health state). LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment\*visit. |
| Secondary | Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD) | Baseline, Week 104 | The QoL-AD (Caregiver Total Score) is a disease-specific measure of quality of life for an Alzheimer's Disease (AD) population administered to the participant's primary caregiver, who answers on behalf of the participant. The assessment consists of 13 items covering physical health, energy, mood, living situations, memory, family, marriage, friends, chores, fun, money, self and life as a whole. The assessment is scored on a 4-point Likert scale with scores ranging from 1 (poor) to 4 (excellent). QoL-AD Total Score is defined as the sum of the 13 items with a scores range from 13 to 52. Higher scores denote a better quality of life. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment\*visit. |
| Secondary | Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE) | Baseline, Week 104 | The MMSE is an instrument used to assess a participant's cognitive function. The instrument is divided into 2 sections. The first section measures orientation, memory, and attention with scores ranging from 0 to 21 (lower scores indicate greater impairment). The second section tests the ability of the participant to name objects, follow verbal and written commands, write a sentence, and copy figures with scores ranging from 0 to 9 (lower scores indicate greater impairment). The range for MMSE Total Score is 0 to 30. Lower scores indicate more impairment. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment\*visit. |
| Secondary | Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels | Baseline, Week 52 | Concentration of the peptide Aβ 1-40 and Aβ 1-42 in plasma measured by immunoassay. The immunoassays for plasma Aβ 1-40 and Aβ 1-42 peptides were modified to render them tolerant to the presence of Solanezumab which would otherwise interfere with non-modified assays. LS Mean was determined by MMRM methodology with baseline, pooled investigator, treatment, visit, feeder visit 1 MMSE status (mild/moderate), concomitant AChEI/Memantine use at baseline (yes/no), baseline age and treatment\*visit. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Baseline through Week 104 | All randomized participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14) | Baseline, Week 104 | Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline \& at least one post baseline observation for ADAS-Cog14. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) | Baseline, Week 104 | Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline \& at least one post baseline observation for ADCS-ADL. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB) | Baseline, Week 104 | Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline \& at least one post baseline observation for CDR-SB. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 104-week Endpoint in Neuropsychiatric Inventory (NPI) | Baseline, Week 104 | Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline \& at least one post baseline observation for NPI. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 104-week Endpoint in Resource Utilization in Dementia - Lite (RUD-Lite) Caregiver Hours | Baseline, Week 104 | Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline \& at least one post baseline observation for RUD-Lite. | hours per day (hr/day) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 104-week Endpoint in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) | Baseline, Week 104 | Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline \& at least one post baseline observation for EQ-5D Proxy. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 104-week Endpoint in Quality of Life in Alzheimer's Disease (QoL-AD) | Baseline, Week 104 | Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline \& at least one post baseline observation for QoL-AD. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 104-week Endpoint in Mini-Mental State Examination (MMSE) | Baseline, Week 104 | Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline \& at least one post baseline observation for MMSE. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to 52-week Endpoint in Plasma Amyloid Beta (Aβ) Levels | Baseline, Week 52 | All Feeder Intent-to-Treat Population: All randomized participants from feeder studies, who received at least one dose of study drug and had baseline \& at least one post baseline observation for plasma Aβ 1-40 and Aβ 1-42. | picograms per milliliter (pg/mL) | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Placebo | SAE | 308 | participants | |
| Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Solanezumab | SAE | 299 | participants | |
| Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Placebo | Other AE | 485 | participants | |
| Assess the Number of Participants With One or More Drug-Related Adverse Events (AEs) or Any Serious AEs (SAEs) | Solanezumab | Other AE | 514 | participants | |
| Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14) | Placebo | 17.58 | Standard Error 0.532 | Units on a scale | |
| Change From Baseline to 104-week Endpoint in Alzheimer's Disease Assessment Scale - Cognitive 14-Item Scale (ADAS-Cog14) | Solanezumab | 17.56 | Standard Error 0.517 | Units on a scale | |
| Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) | Placebo | -26.77 | Standard Error 0.888 | Units on a scale | |
| Change From Baseline to 104-week Endpoint in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) | Solanezumab | -24.77 | Standard Error 0.871 | Units on a scale | |
| Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB) | Placebo | 5.59 | Standard Error 0.174 | Units on a scale | |
| Change From Baseline to 104-week Endpoint in Clinical Dementia Rating - Sum of Boxes (CDR-SB) | Solanezumab | 5.27 | Standard Error 0.169 | Units on a scale |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 723 | |
| Overall Study | STARTED | Solanezumab | 734 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 723 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Solanezumab | 734 | |
| Overall Study | COMPLETED | Placebo | 70 | |
| Overall Study | COMPLETED | Solanezumab | 61 | |
| Overall Study | NOT COMPLETED | Placebo | 653 | |
| Overall Study | NOT COMPLETED | Solanezumab | 673 |
Source ClinicalTrials.gov
Adverse events854
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | Placebo | 51 | 723 | 56 |
| other | Constipation | Gastrointestinal disorders | Solanezumab | 64 | 734 | 71 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 58 | 723 | 72 |
| other | Diarrhoea | Gastrointestinal disorders | Solanezumab | 76 | 734 | 105 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 41 | 723 | 51 |
| other | Vomiting | Gastrointestinal disorders | Solanezumab | 51 | 734 | 70 |
| other | Oedema peripheral | General disorders | Placebo | 31 | 723 | 33 |
| other | Oedema peripheral | General disorders | Solanezumab | 37 | 734 | 38 |
| other | Bronchitis | Infections and infestations | Placebo | 32 | 723 | 47 |
| other | Bronchitis | Infections and infestations | Solanezumab | 43 | 734 | 56 |
1 to 10 of 854Source ClinicalTrials.gov
See all 854 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Solanezumab | ||
| Total, other adverse events | Placebo | 485 | 723 |
| Total, other adverse events | Solanezumab | 514 | 734 |
| Total, serious adverse events | Placebo | 308 | 723 |
| Total, serious adverse events | Solanezumab | 299 | 734 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Solanezumab vs Placebo: serious adverse events |
Source Trial comparisons
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Cancellation Test | Secondary outcome | ConductCognition |
| Delayed Recall Module | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01127633
GET https://conductscience.org/api/trials/v1/NCT01127633/results?page=2