Trial · NCT01900665
Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo
NCT01900665, Phase 3, Terminated, Eli Lilly and Company; results first posted 2018-03-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo. Trials, record NCT01900665. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01900665
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo
- NCT number
- NCT01900665
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 2,129 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Alzheimer's Disease
- Interventions
- Solanezumab, Placebo
- First posted
- 2013-07-16
- Last updated
- 2019-10-09
- Results first posted
- 2018-03-14
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14) | Baseline, Week 80 | The ADAS is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS that was used as the primary efficacy measure consists of 14 items assessing areas of cognitive function most typically impaired in AD: 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. Least Squares (LS) Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. |
| Secondary | Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL) | Baseline, Week 80 | The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both 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 value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. |
| Secondary | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11) | Baseline, Week 80 | The cognitive subscale of ADAS (ADAS Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. |
| Secondary | Change From Baseline in Mini-Mental State Examination (MMSE) | Baseline, Week 80 | 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. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. |
| Secondary | Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) | Baseline, Week 80 | The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both 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 value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. |
| Secondary | Change From Baseline in Functional Activities Questionnaire (FAQ) | Baseline, Week 80 | 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 financial management, shopping, playing games, food preparation, traveling, keeping appointments, keeping track of current events, and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. A negative change indicated an improvement from baseline. FAQ Total Score is the sum of 10 items, ranging from 0 (best possible outcome) to 100 (worst possible outcome). LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. |
| Secondary | Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) | Baseline, Week 80 | 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 value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. |
| Secondary | Change From Baseline in Neuropsychiatric Inventory (NPI) | Baseline, Week 80 | NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. |
| Secondary | Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) | Baseline, Week 80 | Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation and healthcare resource utilization) was gathered from baseline and follow-up interviews. Reported number of hospitalizations per participant up to 76 weeks. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. |
| Secondary | Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) | Baseline, Week 80 | Assesses QoL for AD: 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 to 52). Higher scores indicate greater QoL. Participant's primary caregiver asked to complete same measure. LS Mean value was controlled for baseline value, baseline age, pooled investigator, treatment and visit. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14) | Baseline, Week 80 | All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL) | Baseline, Week 80 | All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11) | Baseline, Week 80 | All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mini-Mental State Examination (MMSE) | Baseline, Week 80 | All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) | Baseline, Week 80 | All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Functional Activities Questionnaire (FAQ) | Baseline, Week 80 | All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) | Baseline, Week 80 | All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data. | Units on a scale | MEAN |
| SECONDARY | Change From Baseline in Neuropsychiatric Inventory (NPI) | Baseline, Week 80 | All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data. | Units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) | Baseline, Week 80 | All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data. | Number of hospitalizations | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Quality of Life in Alzheimer's Disease (QoL-AD) | Baseline, Week 80 | All randomized participants who received at least 1 dose of study drug and had baseline and post baseline data. | Units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group65
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14) | Solanezumab | 6.65 | Standard Error 0.355 | Units on a scale | |
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 14 Item Subscore (ADAS-Cog14) | Placebo | 7.44 | Standard Error 0.356 | Units on a scale | |
| Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL) | Solanezumab | -6.17 | Standard Error 0.318 | Units on a scale | |
| Change From Baseline in Alzheimer's Disease Cooperative Study- Instrumental Activities of Daily Living (ADCS-iADL) | Placebo | -7.17 | Standard Error 0.320 | Units on a scale | |
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11) | Solanezumab | 5.22 | Standard Error 0.284 | Units on a scale | |
| Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive 11 Item Subscore (ADAS-Cog11) | Placebo | 5.90 | Standard Error 0.285 | Units on a scale | |
| Change From Baseline in Mini-Mental State Examination (MMSE) | Solanezumab | -3.17 | Standard Error 0.154 | Units on a scale | |
| Change From Baseline in Mini-Mental State Examination (MMSE) | Placebo | -3.66 | Standard Error 0.156 | Units on a scale | |
| Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) | Solanezumab | -7.42 | Standard Error 0.386 | Units on a scale | |
| Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) | Placebo | -8.77 | Standard Error 0.387 | Units on a scale |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Placebo Controlled Period | STARTED | Solanezumab | 1,057 | |
| Placebo Controlled Period | STARTED | Placebo | 1,072 | |
| Placebo Controlled Period | Received at Least 1 Dose of Study Drug | Solanezumab | 1,054 | |
| Placebo Controlled Period | Received at Least 1 Dose of Study Drug | Placebo | 1,067 | |
| Placebo Controlled Period | COMPLETED | Solanezumab | 914 | |
| Placebo Controlled Period | COMPLETED | Placebo | 908 | |
| Placebo Controlled Period | NOT COMPLETED | Solanezumab | 143 | |
| Placebo Controlled Period | NOT COMPLETED | Placebo | 164 | |
| Open Label Period | STARTED | Solanezumab | 881 | |
| Open Label Period | STARTED | Placebo | 859 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events1,316
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 | Diarrhoea | Gastrointestinal disorders | Solanezumab: Double-Blind Phase | 76 | 1,054 | 86 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo: Double-Blind Phase | 87 | 1,067 | 109 |
| other | Diarrhoea | Gastrointestinal disorders | Solanezumab: Open Label | 23 | 879 | 24 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo: Open Label | 17 | 856 | 18 |
| other | Nausea | Gastrointestinal disorders | Solanezumab: Double-Blind Phase | 54 | 1,054 | 69 |
| other | Nausea | Gastrointestinal disorders | Placebo: Double-Blind Phase | 46 | 1,067 | 63 |
| other | Nausea | Gastrointestinal disorders | Solanezumab: Open Label | 23 | 879 | 32 |
| other | Nausea | Gastrointestinal disorders | Placebo: Open Label | 15 | 856 | 18 |
| other | Nasopharyngitis | Infections and infestations | Solanezumab: Double-Blind Phase | 89 | 1,054 | 114 |
| other | Nasopharyngitis | Infections and infestations | Placebo: Double-Blind Phase | 80 | 1,067 | 99 |
1 to 10 of 1,316Source ClinicalTrials.gov
See all 1,316 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Solanezumab: Double-Blind Phase | ||
| Total, all-cause mortality | Placebo: Double-Blind Phase | ||
| Total, all-cause mortality | Solanezumab: Open Label | ||
| Total, all-cause mortality | Placebo: Open Label | ||
| Total, other adverse events | Solanezumab: Double-Blind Phase | 536 | 1,054 |
| Total, other adverse events | Placebo: Double-Blind Phase | 530 | 1,067 |
| Total, other adverse events | Solanezumab: Open Label | 255 | 879 |
| Total, other adverse events | Placebo: Open Label | 260 | 856 |
| Total, serious adverse events | Solanezumab: Double-Blind Phase | 175 | 1,054 |
| Total, serious adverse events | Placebo: Double-Blind Phase | 203 | 1,067 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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 | Primary outcome | ConductCognition |
| Delayed Recall Module | Primary 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/NCT01900665
GET https://conductscience.org/api/trials/v1/NCT01900665/results?page=2