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[18F]GTP1 for Alzheimer's Disease

Phase 1
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 up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial compares special imaging agents that help detect Alzheimer's disease in people with normal cognition or early to moderate stages of the disease. These agents highlight areas of tau protein build-up in brain scans. The tau imaging agent has been used in studies to stage Alzheimer's disease and assess associations among β-amyloid, tau, and volume loss.

Eligible Conditions
  • Alzheimer's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: [18F]PI-2620 PET, then [18F]GTP1 PETExperimental Treatment2 Interventions
Participants will undergo one \[18F\]PI-2620 PET imaging session, then one \[18F\]GTP1 PET imaging session. Prior to each session, participants will be administered a bolus intravenous injection of approximately 5 millicurie (mCi) of \[18F\]PI-2620 or 7mCi of \[18F\]GTP1.
Group II: [18F]GTP1 PET, then [18F]MK-6240Experimental Treatment2 Interventions
Participants will undergo one \[18F\]GTP1 PET imaging session, then one \[18F\]MK-6240 PET imaging session. Prior to each session, participants will be administered a bolus intravenous injection of approximately 5 millicurie (mCi) of \[18 F\]MK-6240 or 7mCi of \[18F\]GTP1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[18F]GTP1
2019
Completed Phase 2
~390
[18F]PI-2620
2018
Completed Phase 2
~150
[18F]MK-6240
2020
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,555 Previous Clinical Trials
569,323 Total Patients Enrolled
Clinical TrialsStudy DirectorGenentech, Inc.
2,221 Previous Clinical Trials
895,953 Total Patients Enrolled
~8 spots leftby Nov 2025
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