A Phase 2 interventional study of Semorinemab and Placebo in Alzheimer's Disease, sponsored by Genentech, Inc.. Terminated at 133 sites in 13 countries. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by Genentech, Inc. (part of Hoffmann-La Roche) · Phase 2, Interventional, and Treatment
Among 40 studies in Alzheimer Disease by Hoffmann-La Roche — 3 open to participants now, 8 under way, 4 of them phase 3. Alzheimer Disease · Hoffmann-La Roche.
Among the 40 studies in Alzheimer Disease by Hoffmann-La Roche, this one is the 12th largest by enrollment, is one of 2 that started in 2017, is one of 12 in phase 2, and was the 20th registered.
3,967 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.
Browse Alzheimer Disease studies →3 of the 40 studies in Alzheimer Disease by Hoffmann-La Roche are open now, in 12 countries. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in United States, Australia, France
Ages 50–90
Hoffmann-La Roche · Sites in United States, Argentina, Australia and 7 more countries
Ages 55–80
Hoffmann-La Roche · Sites in United States, Argentina, Australia and 12 more countries
Ages 50–90
By country, each count listing its studies:
Of the 642 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 284 take healthy volunteers.
This study: 50 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
40 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 13 · Phase 3 14
First in 2006; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 457 is above the median of 70 across 3,020 interventional studies indexed under Alzheimer Disease.
Median enrollment 247 across the 40 interventional studies. Of the 32 that completed or were terminated, 18 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Genentech, Inc., one of the names counted as Hoffmann-La Roche. Under that name alone:
Genentech, Inc. is the lead sponsor of 517 studies on the registry; 20 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 52 (55%) have results posted.
3 of the studies in Alzheimer Disease by Hoffmann-La Roche that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06402838Hoffmann-La RocheA Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD) | 2026-11-19 |
| NCT07234942Hoffmann-La RocheA Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD) | 2027-03-31 |
| NCT04639050Hoffmann-La RocheBrainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease | 2027-07-31 |
Add all 3 to your calendar (.ics) → With an account.
Among the 40 studies in Alzheimer Disease by Hoffmann-La Roche, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This was a phase II, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of Semorinemab in participants with prodromal to mild Alzheimer's disease. An optional 96-week open-label extension period was available to participants who completed the double-blind treatment period and who, in the judgment of the investigator, would potentially benefit from open-label Semorinemab treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Semorinemab · Drug: [18F]GTP1
Drug: Semorinemab · Drug: [18F]GTP1
Drug: Semorinemab · Drug: [18F]GTP1
Drug: Placebo · Drug: [18F]GTP1
Participants will receive Semorinemab intravenously (IV).
Also known as: RG6100, MTAU9937A, RO7105705
Matching placebo doses of Semorinemab given intravenously (IV).
\[18F\]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
Also known as: RO6880276
Change From Baseline on the CDR-SB
The Clinical Dementia Rating-Sum of Boxes (CDR-SB) rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
Time frame: Baseline and 73 Weeks
Percentage of Participants With Adverse Events
Percentage of participants with at least one adverse event
Time frame: Up to the data cutoff date 15 January 2021 (up to approximately 39 months)
Change From Baseline on the C-SSRS
Categories are as defined in the Classification Algorithm for Suicide Assessment (CASA) based on the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire. SI1: Passive category is "Wish to be dead", SI2: Active-Nonspecific (no method, intent or plan), SI3: Active-Method, but no intent or Plan, SI4: Active-Method and intent, but no plan in C-SSRS. The worst post-baseline suicidal ideation is the highest across post-baseline visits, with highest as SI5 and lowest as SI1. Percentages are based on the total number of subjects in a treatment group. Baseline is the last observation prior to initiation of study drug.
Time frame: Baseline to data cutoff date 15 January 2021 (up to approximately 39 months)
Other Abnormal MRI Findings
Other abnormal MRI findings by visit. For the Double Blind Period, baseline is defined as last results prior to initiation of study drug. For the Open Label Extension Period, baseline is defined as last results prior to entering the open label period.
Time frame: Baseline, Week 9, Week 49, Week 73, Study Treatment Discontinuation, and Week 89
Change From Baseline on the Repeatable Battery for Assessment of Neuropsychological Status (RBANS)
The RBANS is a validated neuropsychological assessment has been shown to be a useful tool in both clinical and research settings. The RBANS consists of ten subtests that are combined to provide five indices, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, and delayed memory). Scores range from 40 to 160 and a higher score indicates better cognitive functioning. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
Time frame: Baseline and 73 weeks
Change From Baseline on the Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Subscale Score
The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
Time frame: Baseline and 73 weeks
Change From Baseline on the Amsterdam Instrumental Activity of Daily Living (iADL) Questionnaire
The Amsterdam iADL questionnaire is an informant-based instrument for measuring iADL problems in participants with dementia. This instrument consists of 70 items, scored on a 5-point scale, that uses item response theory for scoring. Items presented to the informant are tailored to responses to earlier items; thus each administration of the Amsterdam iADL may consist of less than the total of 70 items. The resulting score ranges from 20 to 80 with lower scores indicating poorer performance. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
Time frame: Baseline and 73 weeks
Change From Baseline on the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living Inventory
The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
Time frame: Baseline and 73 weeks
Serum Concentrations of Semorinemab at Specified Timepoints
Serum concentrations of Semorinemab at specified timepoints.
Time frame: Up to 109 weeks
Presence of Anti-drug Antibodies During the Study Relative to Their Presence at Baseline
Presence of anti-drug antibodies during the study relative to their presence at baseline.
Time frame: Up to 109 weeks
| Milestone | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period |
|---|---|---|---|---|
| Started | 135 | 94 | 136 | 92 |
| Completed | 1 | 0 | 2 | 0 |
| Not completed | 134 | 94 | 134 | 92 |
| Withdrew: Caregiver unavailability | 1 | 1 | 0 | 0 |
| Withdrew: Research department closure | 0 | 0 | 1 | 0 |
| Withdrew: Caregiver and participant withdrew consent | 0 | 0 | 1 | 0 |
| Withdrew: Medical monitor decision | 1 | 0 | 0 | 0 |
| Withdrew: Participant non-compliance | 0 | 0 | 1 | 0 |
| Withdrew: Drug interrupted for too long due to prohibited med | 0 | 0 | 1 | 0 |
| Withdrew: Participant non compliance with concomitant medications | 0 | 0 | 1 | 0 |
| Withdrew: Caregiver passed away | 1 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 2 | 2 | 2 |
| Withdrew: Protocol deviation | 2 | 1 | 3 | 1 |
| Withdrew: Study terminated by sponsor | 101 | 75 | 100 | 69 |
| Withdrew: Withdrawal by subject | 14 | 6 | 14 | 12 |
| Withdrew: Adverse event | 10 | 7 | 6 | 5 |
| Withdrew: Death | 2 | 0 | 2 | 1 |
| Withdrew: Lost to follow-up | 2 | 1 | 1 | 0 |
| Withdrew: Participant no longer has study partner | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by caregiver | 0 | 1 | 0 | 0 |
| Withdrew: Caregiver passed away & family moved out of state | 0 | 0 | 1 | 0 |
| Withdrew: Absence of consistent and reliable caregiver | 0 | 0 | 0 | 1 |
The Clinical Dementia Rating-Sum of Boxes (CDR-SB) rates impairment in 6 categories (memory, orientation, judgement and problem solving, community affairs, home and hobbies and personal care) on a 5-point scale in which no impairment = 0, questionable impairment = 0.5 and mild, moderate and severe impairment = 1, 2 and 3 respectively. The score range is from 0 to 18 with a high score indicating a high disease severity. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
| Units on a scale | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period |
|---|---|---|---|---|
| Change From Baseline on the CDR-SB | 2.19 ± 0.226 | 2.36 ± 0.268 | 2.36 ± 0.222 | 2.41 ± 0.27 |
Percentage of participants with at least one adverse event
| Percentage of participants | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period | Dose 2 Semorinemab Open Label Extension Period |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events | 93.1 | 88.8 | 94.7 | 92.2 | 47.5 |
The RBANS is a validated neuropsychological assessment has been shown to be a useful tool in both clinical and research settings. The RBANS consists of ten subtests that are combined to provide five indices, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, and delayed memory). Scores range from 40 to 160 and a higher score indicates better cognitive functioning. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
| Score on a scale | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period |
|---|---|---|---|---|
| Change From Baseline on the Repeatable Battery for Assessment of Neuropsychological Status (RBANS) | -5.53 ± 0.787 | -5.25 ± 0.93 | -4.62 ± 0.765 | -6.15 ± 0.926 |
The ADAS-Cog-13 assesses multiple cognitive domains including memory, comprehension, praxis, orientation, and spontaneous speech. Most of these are assessed by tests although some are rated by the clinician on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 further items: delayed word recall and total digit cancellation. The score range for ADAS-Cog-13 is from 0 to 85 with high scores representing severe dysfunction. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
| Score on a scale | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period |
|---|---|---|---|---|
| Change From Baseline on the Alzheimer's Disease Assessment Scale-Cognitive Subscale 13 (ADAS-Cog-13) Subscale Score | 6.56 ± 0.777 | 8.68 ± 0.937 | 6 ± 0.769 | 7.58 ± 0.932 |
The Amsterdam iADL questionnaire is an informant-based instrument for measuring iADL problems in participants with dementia. This instrument consists of 70 items, scored on a 5-point scale, that uses item response theory for scoring. Items presented to the informant are tailored to responses to earlier items; thus each administration of the Amsterdam iADL may consist of less than the total of 70 items. The resulting score ranges from 20 to 80 with lower scores indicating poorer performance. A decrease in the outcome measure from baseline corresponds to disease worsening. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
| Score on a scale | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period |
|---|---|---|---|---|
| Change From Baseline on the Amsterdam Instrumental Activity of Daily Living (iADL) Questionnaire | -6.59 ± 0.856 | -6.55 ± 0.999 | -6.92 ± 0.824 | -7.31 ± 1.013 |
The ADCS-ADL (Alzheimer's Disease Cooperative Study-Activities of Daily Living) is the scale most widely used to assess functional outcomes in participants with AD. The ADCS-ADL covers both basic ADL (e.g., eating and toileting) and more complex 'instrumental' ADL or iADL (e.g., using the telephone, managing finances and preparing a meal). The ADCS-ADL consists of 23 questions with a score range of 0 to 78 where a higher score represents better function. The difference in mean change from Baseline to Week 73 between Semorinemab doses and Placebo treated participants was estimated.
| Score on a scale | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period |
|---|---|---|---|---|
| Change From Baseline on the Alzheimer's Disease Cooperative Study Group-Activities of Daily Living Inventory | -8.55 ± 0.996 | -9.52 ± 1.179 | -7.75 ± 0.986 | -7.99 ± 1.183 |
Serum concentrations of Semorinemab at specified timepoints.
| ug/mL | Dose 1 Semorinemab Double Blind and Open Label Extension Periods | Dose 2 Semorinemab Double Blind and Open Label Extension Periods | Dose 3 Semorinemab Double Blind and Open Label Extension Periods |
|---|---|---|---|
| Week 1, 0-4 Hours Predose | NA ± NA | NA ± NA | NA ± NA |
| Week 1, 1 Hour Postdose | 472 ± 131 | 1580 ± 496 | 2690 ± 689 |
| Week 1, 2 Hours Postdose | 476 ± 123 | 1510 ± 419 | 2600 ± 707 |
| Week 1, 4 Hours postdose | 463 ± 135 | 1370 ± 405 | 2570 ± 785 |
| Week 3, 0-4 hours Predose | 184 ± 52.7 | 601 ± 211 | 1100 ± 449 |
| Week 3, 30 min Post dose | 718 ± 198 | 2320 ± 581 | 4190 ± 1010 |
| Week 5, 0-4 Hours Predose | 318 ± 81.5 | 955 ± 256 | 1920 ± 614 |
| Week 5, 30 min Postdose | 908 ± 508 | 2780 ± 695 | 4860 ± 1250 |
| Week 9, 0-4 hours Predose | 344 ± 128 | 961 ± 288 | 1840 ± 513 |
| Week 9, 30 Minutes Postdose | 889 ± 321 | 2790 ± 757 | 4960 ± 1270 |
| Week 13, 0-4 Hours Predose | 360 ± 105 | 1060 ± 333 | 1910 ± 545 |
| Week 13, 30 Minutes Postdose | 998 ± 896 | 2900 ± 668 | 4880 ± 1250 |
| Week 17 | — | — | 1750 ± NA |
| Week 17, 0-4 Hours Predose | 386 ± 116 | 1040 ± 316 | 1890 ± 522 |
| Week 17, 30 Minutes Postdose | 819 ± 242 | 2930 ± 902 | 4770 ± 1270 |
| Week 33, 0-4 Hours Predose | 404 ± 134 | 960 ± 277 | 2050 ± 648 |
| Week 33, 30 Minutes Postdose | 801 ± 260 | 2540 ± 853 | 4800 ± 1200 |
| Week 49, 0-4 Hours Predose | 377 ± 105 | 1060 ± 332 | 2160 ± 605 |
| Week 49, 30 Minutes Postdose | 871 ± 260 | 2810 ± 967 | 4960 ± 1030 |
| Week 65 | — | — | 2100 ± NA |
| Week 65, 0-4 Hours Predose | 405 ± 127 | 1170 ± 276 | 2020 ± 681 |
| Week 65, 30 Minutes Postdose | 963 ± 401 | 2930 ± 830 | 4710 ± 1450 |
| Week 73 | 327 ± 154 | 1030 ± 451 | 1830 ± 752 |
| Week 73, 0-4 Hours Predose | — | 382 ± NA | — |
| Week 73, 1 Hour Postdose | — | 1910 ± NA | — |
| Week 73, 2 Hours Postdose | — | 1740 ± NA | — |
| Week 73, 4 Hours Postdose | — | 1710 ± NA | — |
| Week 77 OLE, 0-4 Hours Predose | 180 ± 71.0 | 724 ± 167 | 1030 ± 345 |
| Week 77 OLE, 1 hour Postdose | 1700 ± 523 | 2460 ± 868 | 2670 ± 707 |
| Week 77 OLE, 2 hours Postdose | 1830 ± 552 | 2270 ± 442 | 2510 ± 579 |
| Week 77 OLE, 4 hours Postdose | 1850 ± 516 | 2270 ± 480 | 2790 ± 558 |
| Week 93 OLE, 0-4 Hours Pre-dose | 632 ± 37.5 | 1040 ± 113 | 1290 ± 307 |
| Week 93 OLE, 30 Minutes Postdose | 1920 ± 431 | 2570 ± 91.9 | 2880 ± 492 |
| Week 109 OLE, 0-4 Hours Predose | — | 1270 ± NA | — |
| Week 109 OLE, 30 Minutes Postdose | — | 3330 ± NA | — |
Presence of anti-drug antibodies during the study relative to their presence at baseline.
| Percentage of participants | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period |
|---|---|---|---|---|
| Baseline | 0 | 0 | 0 | 0 |
| Post-baseline | — | 0 | 0 | 0 |
Categories are as defined in the Classification Algorithm for Suicide Assessment (CASA) based on the Columbia Suicide Severity Rating Scale (C-SSRS) questionnaire. SI1: Passive category is "Wish to be dead", SI2: Active-Nonspecific (no method, intent or plan), SI3: Active-Method, but no intent or Plan, SI4: Active-Method and intent, but no plan in C-SSRS. The worst post-baseline suicidal ideation is the highest across post-baseline visits, with highest as SI5 and lowest as SI1. Percentages are based on the total number of subjects in a treatment group. Baseline is the last observation prior to initiation of study drug.
| Participants | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period | Dose 2 Semorinemab Open Label Extension Period |
|---|---|---|---|---|---|
| Missing/No Events | 1 | 1 | 2 | 0 | 3 |
| Missing/SI1 | 0 | 0 | 0 | 0 | 0 |
| Missing/SI2 | 0 | 0 | 0 | 0 | 0 |
| Missing/SI3 | 0 | 0 | 0 | 0 | 0 |
| Missing/SI4 | 0 | 0 | 0 | 0 | 0 |
| Missing/Missing | 0 | 0 | 0 | 0 | 0 |
| No Event/No Event | 119 | 80 | 123 | 83 | 336 |
| No Event/SI1 | 3 | 3 | 2 | 4 | 5 |
| No Event/ SI2 | 0 | 1 | 1 | 0 | 1 |
| No Event/SI3 | 0 | 0 | 0 | 0 | 0 |
| No Event/ SI4 | 0 | 0 | 0 | 0 | 0 |
| No Event/ Missing | 1 | 0 | 0 | 1 | 1 |
| SI1/No Event | 3 | 3 | 1 | 1 | 8 |
| SI1/SI1 | 0 | 0 | 0 | 0 | 1 |
| SI1/SI2 | 1 | 0 | 0 | 0 | 0 |
| SI1/SI3 | 0 | 0 | 0 | 0 | 0 |
| SI1/SI4 | 1 | 0 | 0 | 0 | 0 |
| SI1/Missing | 0 | 0 | 0 | 0 | 0 |
| SI2/No Event | 0 | 1 | 2 | 0 | 1 |
| SI2/SI1 | 0 | 0 | 1 | 0 | 2 |
| SI2/SI2 | 0 | 0 | 0 | 1 | 0 |
| SI2/SI3 | 0 | 0 | 0 | 0 | 0 |
| SI2/SI4 | 0 | 0 | 0 | 0 | 0 |
| SI2/Missing | 0 | 0 | 0 | 0 | 0 |
| SI3/No Event | 1 | 0 | 0 | 0 | 1 |
| SI3/SI1 | 0 | 0 | 0 | 0 | 0 |
| SI3/SI2 | 0 | 0 | 0 | 0 | 0 |
| SI3/SI3 | 0 | 0 | 0 | 0 | 0 |
| SI3/SI4 | 0 | 0 | 0 | 0 | 0 |
| SI3/Missing | 0 | 0 | 0 | 0 | 0 |
| SI4/No Event | 0 | 0 | 0 | 0 | 0 |
| SI4/SI1 | 0 | 0 | 0 | 0 | 0 |
| SI4/SI2 | 0 | 0 | 0 | 0 | 0 |
| SI4/SI3 | 0 | 0 | 0 | 0 | 1 |
| SI4/Missing | 0 | 0 | 0 | 0 | 0 |
Other abnormal MRI findings by visit. For the Double Blind Period, baseline is defined as last results prior to initiation of study drug. For the Open Label Extension Period, baseline is defined as last results prior to entering the open label period.
| Number of participants | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period | Dose 2 Semorinemab Open Label Extension Period |
|---|---|---|---|---|---|
| Cerebrovascular Pathology, Baseline | 3 | 0 | 2 | 1 | 5 |
| CNS Trauma, Baseline | 0 | 0 | 0 | 1 | 1 |
| Intracranial Tumor, Baseline | 0 | 0 | 3 | 2 | 4 |
| Lacunar Infarct, Baseline | 13 | 3 | 11 | 6 | 23 |
| Superficial Hemosiderosis, Baseline | 3 | 0 | 2 | 0 | 7 |
| Territorial Infarct, Baseline | 3 | 1 | 0 | 0 | 4 |
| Vasogenic Edema/Sulcal Effusion, Baseline | 0 | 0 | 0 | 0 | 0 |
| Cerebrovascular Pathology, Week 9 | 0 | 1 | 0 | 0 | — |
| CNS Trauma, Week 9 | 0 | 0 | 0 | 0 | — |
| Intracranial Tumor, Week 9 | 0 | 0 | 0 | 0 | — |
| Lacunar Infarct, Week 9 | 0 | 1 | 0 | 0 | — |
| Superficial Hemosiderosis, Week 9 | 3 | 0 | 0 | 1 | — |
| Territorial Infarct, Week 9 | 0 | 0 | 0 | 0 | — |
| Vasogenic Edema/Sulcal Effusion, Week 9 | 0 | 0 | 1 | 0 | — |
| Cerebrovascular Pathology, Week 49 | 0 | 0 | 0 | 0 | — |
| CNS Trauma, Week 49 | 0 | 0 | 0 | 0 | — |
| Intracranial Tumor, Week 49 | 0 | 0 | 0 | 0 | — |
| Lacunar Infarct, Week 49 | 0 | 0 | 0 | 0 | — |
| Superficial Hemosiderosis, Week 49 | 1 | 1 | 1 | 0 | — |
| Territorial Infarct, Week 49 | 0 | 0 | 0 | 0 | — |
| Vasogenic Edema/Sulcal Effusion, Week 49 | 0 | 0 | 0 | 0 | — |
| Cerebrovascular Pathology, Week 73 | 0 | 0 | 0 | 0 | — |
| CNS Trauma, Week 73 | 0 | 0 | 0 | 0 | — |
| Intracranial Tumor, Week 73 | 1 | 0 | 0 | 0 | — |
| Lacunar Infarct, Week 73 | 0 | 1 | 0 | 0 | — |
| Superficial Hemosiderosis, Week 73 | 0 | 1 | 0 | 1 | — |
| Territorial Infarct, Week 73 | 0 | 0 | 0 | 0 | — |
| Vasogenic Edema/Sulcal Effusion, Week 73 | 1 | 0 | 0 | 0 | — |
| Cerebrovascular Pathology, Study Treatment Early Discontinuation | 0 | 0 | 0 | 0 | — |
| CSN Trauma, Study Treatment Early Discontinuation | 0 | 0 | 0 | 0 | — |
| Intracranial Tumor, Study Treatment Early Discontinuation | 0 | 0 | 0 | 0 | — |
| Lucunar Infarct, Study Treatment Early Discontinuation | 1 | 0 | 0 | 0 | — |
| Superficial Hemosiderosis, Study Treatment Early Discontinuation | 1 | 0 | 0 | 0 | — |
| Territorial Infarct, Study Treatment Early Discontinuation | 0 | 0 | 0 | 0 | — |
| Vasogenic Edema/Sulcal Effusion, Study Treatment Early Discontinuation | 0 | 0 | 0 | 0 | — |
| Cerebrovascular Pathology, Week 89 Open Label Extension (OLE) | — | — | — | — | 0 |
| CNS Trauma, Week 89 OLE | — | — | — | — | 0 |
| Intracranial Tumor, Week 89 OLE | — | — | — | — | 1 |
| Lacunar Infarct, Week 89 OLE | — | — | — | — | 0 |
| Superficial Hemosiderosis, Week 89 OLE | — | — | — | — | 0 |
| Territorial Infarct, Week 89 OLE | — | — | — | — | 0 |
| Vasogenic Edema/Sulcal Effusion, Week 89 OLE | — | — | — | — | 1 |
Collected over From the first study drug to the data cutoff date: 15 January 2021 (up to approximately 39 months). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo Double Blind Period | 2/130 (1.5%) | 14/130 (10.8%) | 76/130 (58.5%) |
| Dose 1 Semorinemab Double Blind Period | 0/89 (0%) | 17/89 (19.1%) | 57/89 (64%) |
| Dose 2 Semorinemab Double Blind Period | 1/132 (0.8%) | 17/132 (12.9%) | 88/132 (66.7%) |
| Dose 3 Semorinemab Double Blind Period | 1/90 (1.1%) | 16/90 (17.8%) | 60/90 (66.7%) |
| Dose 2 Semorinemab Open Label | 1/360 (0.3%) | 17/360 (4.7%) | 76/360 (21.1%) |
| Event | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period | Dose 2 Semorinemab Open Label |
|---|---|---|---|---|---|
| PneumoniaInfections and infestations | 1/130 | 1/89 | 1/132 | 3/90 | 1/360 |
| AgitationPsychiatric disorders | 0/130 | 1/89 | 0/132 | 2/90 | 0/360 |
| FallInjury, poisoning and procedural complications | 2/130 | 0/89 | 1/132 | 1/90 | 0/360 |
| Hip fractureInjury, poisoning and procedural complications | 0/130 | 1/89 | 2/132 | 0/90 | 0/360 |
| SyncopeNervous system disorders | 0/130 | 1/89 | 2/132 | 0/90 | 0/360 |
| AnaemiaBlood and lymphatic system disorders | 0/130 | 1/89 | 0/132 | 0/90 | 0/360 |
| Sinus node dysfunctionCardiac disorders | 0/130 | 1/89 | 0/132 | 0/90 | 0/360 |
| EnteritisGastrointestinal disorders | 0/130 | 1/89 | 0/132 | 0/90 | 0/360 |
| HaemorrhoidsGastrointestinal disorders | 0/130 | 1/89 | 0/132 | 0/90 | 0/360 |
| Lower gastrointestinal haemorrhageGastrointestinal disorders | 0/130 | 1/89 | 0/132 | 0/90 | 0/360 |
| Event | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period | Dose 2 Semorinemab Open Label |
|---|---|---|---|---|---|
| FallInjury, poisoning and procedural complications | 22/130 | 14/89 | 22/132 | 7/90 | 18/360 |
| NasopharyngitisInfections and infestations | 11/130 | 5/89 | 18/132 | 12/90 | 2/360 |
| Upper respiratory tract infectionInfections and infestations | 15/130 | 6/89 | 7/132 | 5/90 | 4/360 |
| Infusion related reactionInjury, poisoning and procedural complications | 6/130 | 10/89 | 11/132 | 6/90 | 5/360 |
| AnxietyPsychiatric disorders | 3/130 | 10/89 | 6/132 | 6/90 | 1/360 |
| HypertensionVascular disorders | 7/130 | 4/89 | 14/132 | 5/90 | 4/360 |
| NauseaGastrointestinal disorders | 0/130 | 9/89 | 8/132 | 4/90 | 3/360 |
| DizzinessNervous system disorders | 12/130 | 5/89 | 6/132 | 7/90 | 4/360 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 8/130 | 6/89 | 10/132 | 8/90 | 8/360 |
| Urinary tract infectionInfections and infestations | 10/130 | 4/89 | 10/132 | 5/90 | 10/360 |
| Age, Continuous(Year) | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period | Total |
|---|---|---|---|---|---|
| Mean | 69.7 ± 7.3 | 70.2 ± 6.7 | 69.3 ± 7.1 | 69.6 ± 6.7 | 69.6 ± 6.9 |
| Sex: Female, Male(Participants) | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period | Total |
|---|---|---|---|---|---|
| Female | 75 | 51 | 79 | 48 | 253 |
| Male | 60 | 43 | 57 | 44 | 204 |
| Ethnicity (NIH/OMB)(Participants) | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 4 | 5 | 3 | 13 |
| Not Hispanic or Latino | 126 | 80 | 125 | 79 | 410 |
| Unknown or Not Reported | 8 | 10 | 6 | 10 | 34 |
| Race (NIH/OMB)(Participants) | Placebo Double Blind Period | Dose 1 Semorinemab Double Blind Period | Dose 2 Semorinemab Double Blind Period | Dose 3 Semorinemab Double Blind Period | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 0 | 1 |
| Asian | 0 | 1 | 2 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 0 | 1 |
| Black or African American | 0 | 2 | 1 | 1 | 4 |
| White | 129 | 83 | 128 | 82 | 422 |
| More than one race | 1 | 1 | 0 | 0 | 2 |
| Unknown or Not Reported | 4 | 6 | 5 | 9 | 24 |
Showing the first 100 of 133 sites across 13 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Oct 2017 to primary completion in Jan 2021, 39 months.
Results were first posted in Mar 2022, 1 year 2 months after primary completion.
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Studies of the drug tested here: Semorinemab