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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 end of study (approximately 4 years and 7 months)

Summary

This trial is testing semorinemab, a medication for people with moderate Alzheimer's Disease. The goal is to see if it can help improve their symptoms and understand how it works in the body. The study will also check if the medication is safe to use.

Eligible Conditions
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to end of study (approximately 4 years and 7 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to end of study (approximately 4 years and 7 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Therapeutic procedure
Change From Baseline to Last Visit of Double-Blind Treatment Period on the Mini-Mental State Examination (MMSE)
Percentage of Participants With Adverse Events
+7 more

Side effects data

From 2023 Phase 2 trial • 272 Patients • NCT03828747
10%
Infusion related reaction
10%
Fall
8%
Headache
8%
Urinary tract infection
7%
Anxiety
7%
Depression
7%
Nasopharyngitis
6%
Arthralgia
6%
Dizziness
6%
Agitation
6%
Hypertension
5%
Insomnia
5%
Diarrhoea
1%
Cerebellar infarction
1%
Subarachnoid haemorrhage
1%
Stress cardiomyopathy
1%
Inguinal hernia strangulated
1%
SARS-CoV-2 test positive
1%
Dehydration
1%
Colitis
1%
Diabetic metabolic decompensation
1%
Ovarian cancer
1%
Dysarthria
1%
Seizure
1%
Upper motor neurone lesion
1%
Renal failure
1%
Peripheral artery thrombosis
1%
Femoral neck fracture
1%
Adenocarcinoma metastatic
1%
Invasive ductal breast carcinoma
1%
Squamous cell carcinoma
1%
Atrial fibrillation
1%
Bradycardia
1%
Death
1%
COVID-19
1%
Cystitis
1%
Gastroenteritis
1%
Craniocerebral injury
1%
Joint dislocation
1%
Patella fracture
1%
Transitional cell carcinoma recurrent
1%
Syncope
1%
Leukocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Semorinemab (Double Blind)
Semorinemab (OLE)

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
1,563 Previous Clinical Trials
569,817 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,227 Previous Clinical Trials
896,150 Total Patients Enrolled
~40 spots leftby Dec 2025
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