A Phase 3 interventional study of Crenezumab in Alzheimer's Disease, sponsored by Hoffmann-La Roche. Terminated at 66 sites in 16 countries. Per ClinicalTrials.gov, last updated 2020-07-13.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
Among 27 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 27 studies in Alzheimer Disease by Hoffmann-La Roche, this one is the 18th largest by enrollment, is one of 3 that started in 2018, is one of 14 in phase 3, and was the 13th registered.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's enrollment of 149 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →3 of the 27 studies in Alzheimer Disease by Hoffmann-La Roche are open now, in 12 countries. Each count lists the studies.
Of the 641 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 54 (8%) stop at 75 or younger; 34 take children under 18; 283 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →27 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 7 · Phase 2 7 · Phase 3 14
First in 2006; this study’s year is marked. 3 started in 2018.
Median enrollment 389 across the 27 interventional studies. Of the 19 that completed or were terminated, 13 (68%) have results posted.
Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) 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 |
Among the 27 studies in Alzheimer Disease by Hoffmann-La Roche, from their registry updates:
In the BN40031 OLE study, a dose of crenezumab of 60 mg/kg intravenous (IV) every 4 weeks (Q4W) will be offered to all participants who complete Study BN29552 or BN29553 and who meet eligibility criteria in order to evaluate safety in participants on long-term crenezumab treatment and to investigate the effect of crenezumab on the underlying disease process and disease course as an exploratory efficacy objective.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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 drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
Drug: Crenezumab
Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).
Drug: Crenezumab
Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
Also known as: RO5490245
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Time frame: Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
Percentage of Participants With Anti-Crenezumab Antibodies
Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.
Time frame: Baseline up to end of study (up to 54 weeks).
The study was conducted at 66 centers in 16 countries.
| Milestone | Parent Placebo | Parent Crenezumab |
|---|---|---|
| Started | 76 | 73 |
| Completed | 0 | 0 |
| Not completed | 76 | 73 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Study terminated by sponsor | 74 | 70 |
| Withdrew: Other | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 2 |
An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
| Percentage of Participants | Parent Placebo | Parent Crenezumab |
|---|---|---|
| AEs | 32.9 | 42.5 |
| SAEs | 3.9 | 5.5 |
Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.
No measurements were reported for this outcome.
Collected over Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parent Placebo | 0/76 (0%) | 3/76 (3.9%) | 4/76 (5.3%) |
| Parent Crenezumab | 0/73 (0%) | 4/73 (5.5%) | 4/73 (5.5%) |
| Event | Parent Placebo | Parent Crenezumab |
|---|---|---|
| OPTIC ISCHAEMIC NEUROPATHYEye disorders | 0/76 | 1/73 |
| PNEUMONIAInfections and infestations | 0/76 | 1/73 |
| UROSEPSISInfections and infestations | 0/76 | 1/73 |
| FALLInjury, poisoning and procedural complications | 0/76 | 1/73 |
| INCARCERATED INGUINAL HERNIAGastrointestinal disorders | 1/76 | 0/73 |
| RECTAL HAEMORRHAGEGastrointestinal disorders | 1/76 | 0/73 |
| CEREBROVASCULAR ACCIDENTNervous system disorders | 1/76 | 0/73 |
| Event | Parent Placebo | Parent Crenezumab |
|---|---|---|
| FALLInjury, poisoning and procedural complications | 4/76 | 4/73 |
| Age, Continuous(Years) | Parent Placebo | Parent Crenezumab | Total |
|---|---|---|---|
| Mean | 73.8 ± 7.6 | 72.0 ± 7.6 | 72.9 ± 7.6 |
| Sex: Female, Male(Participants) | Parent Placebo | Parent Crenezumab | Total |
|---|---|---|---|
| Female | 37 | 38 | 75 |
| Male | 39 | 35 | 74 |
| Race/Ethnicity, Customized(Participants) | Parent Placebo | Parent Crenezumab | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 3 | 9 |
| Not Hispanic or Latino | 69 | 69 | 138 |
| Not Stated | 1 | 1 | 2 |
| Race/Ethnicity, Customized(Participants) | Parent Placebo | Parent Crenezumab | Total |
|---|---|---|---|
| Asian | 4 | 2 | 6 |
| Black or African American | 0 | 1 | 1 |
| Unknown | 0 | 3 | 3 |
| White | 72 | 67 | 139 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in May 2019, 13 months.
Results were first posted in Jun 2020, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Crenezumab