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Monoclonal Antibodies

Semorinemab for Alzheimer's Disease

Phase 2
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to clinical cut off date (ccod) of july 20, 2021 (approximately 2.5 years)
Awards & highlights

Study Summary

This trial will study whether semorinemab is effective and safe in treating patients with moderate Alzheimer's disease. The study will last for several months and will have patients in a placebo group and a treatment group.

Eligible Conditions
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to clinical cut off date (ccod) of july 20, 2021 (approximately 2.5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to clinical cut off date (ccod) of july 20, 2021 (approximately 2.5 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alzheimer's Disease
Change From Baseline to Last Visit of Double-Blind Treatment Period in Functional Capacities as Measured by the Alzheimer's Disease Cooperative Study-Daily Living Inventory (ADCS-ADL)
Secondary outcome measures
Therapeutic procedure
Change From Baseline to Last Visit of Double-Blind Treatment Period on the Mini-Mental State Examination (MMSE)
Incidence of Anti-drug Antibodies (ADAs) During the Study Relative to the Prevalence of ADAs at Baseline
+9 more

Side effects data

From 2023 Phase 2 trial • 272 Patients • NCT03828747
5%
Urinary tract infection
5%
Fall
4%
Arthralgia
3%
Agitation
2%
Insomnia
2%
Anxiety
2%
Syncope
2%
Dizziness
2%
Hypertension
2%
Infusion related reaction
1%
Abdominal pain
1%
Arrhythmia
1%
Sinus node dysfunction
1%
Cholecystitis
1%
Headache
1%
Peripheral artery aneurysm
1%
COVID-19
1%
COVID-19 pneumonia
1%
Aggression
1%
Hypotension
1%
Chronic Exacerbated Cholecystitis on the Background of Urolithiasis
1%
Bladder cancer recurrent
1%
Diarrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Semorinemab (OLE)
Placebo
Semorinemab (Double Blind)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemorinemabExperimental Treatment2 Interventions
Semorinemab will be administered intravenously in the double-blind treatment period, and semorinemab will be administered intravenously in the optional open-label extension period.
Group II: PlaceboPlacebo Group2 Interventions
Placebo will be administered intravenously in the double-blind treatment period and semorinemab will be administered intravenously in the optional open-label extension.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semorinemab
2019
Completed Phase 2
~280
[18F]GTP1
2019
Completed Phase 2
~390

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,538 Previous Clinical Trials
567,408 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,288 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots for potential participants in this research?

"Unfortunately, this trial is not currently taking on any new patients. It was initially posted in January 30th 2019 and last updated on September 1st, 2022. If you are looking for other studies to join, there are 546 concurrent medical trials searching for Alzheimer's disease (AD) participants and one study seeking enrolment of those with Semorinemab."

Answered by AI

How hazardous is Semorinemab for individuals?

"There is a degree of safety data connected to semorinemab, which is why it was rated at 2 on our scale. However, as this trial remains in its Phase 2 stage, there isn't yet any evidence for efficacy."

Answered by AI

How many healthcare facilities have implemented this trial?

"31 different medical institutions are presently conducting this trial, in locations such as Abington, Fort Myers and Wellington. To reduce the stress of travelling for participants, it is advisable to pick a clinic that is closest to you."

Answered by AI

Have prior experiments explored the effects of Semorinemab?

"Currently, 1 clinical trial studying Semorinemab is being conducted. None of these trials are in the late Phase 3 stage. Toulouse and New jersey are two hubs for this research with a total of 51 sites around the world running studies on the potential treatment."

Answered by AI

Has a clinical trial like this ever been undertaken previously?

"Since 2019, Genentech has sponsored a single trial for semorinemab across 32 cities and 4 countries. The first phase of the study was completed with 272 participants in that same year and 18,328 studies have concluded since then."

Answered by AI

How many participants are enrolled in this research endeavor?

"Unfortunately, the aforementioned clinical trial has closed; with its first post dating to January 30th 2019 and most recent update on September 1st 2022. Currently, there are 546 trials accepting patients exhibiting Alzheimer's disease and a lone medical study utilizing Semorinemab that is enrolling volunteers."

Answered by AI

What qualifications are necessary for participants to be included in this research endeavor?

"To qualify for this clinical trial, candidates must be diagnosed with Alzheimer's disease (AD) and aged between 50 and 85. The total number of participants required is 272 individuals."

Answered by AI

Does this clinical trial accept participants of a minor age?

"This trial's entry requirements stipulate that those interested in joining must be between 50 and 85 years old."

Answered by AI
~44 spots leftby Mar 2025