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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 approximately 1 hour after injection of [18f]mk-6240

Awards & highlights

Study Summary

This trial will compare three different imaging drugs to see which is best at detecting tau protein buildup in the brains of people with early Alzheimer's disease.

Eligible Conditions

Alzheimer's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 1 hour after injection of [18f]pi-2620

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 1 hour after injection of [18f]pi-2620

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 hour after injection of [18f]pi-2620 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Brain tau burden as measured by [18F]GTP1 - PET

Brain tau burden as measured by [18F]MK-6240 - PET

Brain tau burden as measured by [18F]PI-2620 - PET

+1 more

Side effects data

From 2023 Phase 2 trial • 272 Patients • NCT03828747

10%

Infusion related reaction

10%

Fall

Headache

Anxiety

Depression

Nasopharyngitis

Urinary tract infection

Dizziness

Agitation

Hypertension

Arthralgia

Insomnia

Diarrhoea

SARS-CoV-2 test positive

Stress cardiomyopathy

Subarachnoid haemorrhage

Dehydration

Colitis

Diabetic metabolic decompensation

Ovarian cancer

Dysarthria

Seizure

Upper motor neurone lesion

Renal failure

Peripheral artery thrombosis

Inguinal hernia strangulated

Femoral neck fracture

Adenocarcinoma metastatic

Invasive ductal breast carcinoma

Squamous cell carcinoma

Atrial fibrillation

Bradycardia

Death

COVID-19

Cystitis

Gastroenteritis

Craniocerebral injury

Joint dislocation

Patella fracture

Transitional cell carcinoma recurrent

Syncope

Leukocytosis

100%

80%

60%

40%

20%

Study treatment Arm

Semorinemab (Double Blind)

Semorinemab (OLE)

Placebo

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor

1,539 Previous Clinical Trials

567,649 Total Patients Enrolled

Clinical TrialsStudy DirectorGenentech, Inc.

2,199 Previous Clinical Trials

888,462 Total Patients Enrolled

Frequently Asked Questions

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

What is the upper limit of participants in this clinical experiment?

"Yes, clinicaltrials.gov indicates that this experiment is actively enrolling patients-- originally posted on October 26th 2020 and last modified on November 23rd 2022. Sixty participants are required for the single-site trial."

Answered by AI

What qualifications must one possess to be eligible for participation in this study?

"This clinical trial is looking for approximately 60 Alzheimer's disease (AD) sufferers aged between 50 and 90. To be considered, patients must meet these requirements."

Answered by AI

What hazards, if any, are associated with the administration of [18F]GTP1?

"The safety of [18F]GTP1 is estimated to be a 1 due to the preliminary nature of this Phase 1 trial. This translates into limited data regarding efficacy and safety being available at present."

Answered by AI

Is enrollment for this research program still ongoing?

"As per clinicaltrials.gov, this investigation is seeking out volunteers with the listing first appearing on October 26th 2020 and most recently updated November 23rd 2022."

Answered by AI

Are geriatric individuals being sought for this trial?

"Patients aged between 50 - 90 are eligible to enroll in this trial, while those younger than 18 have 23 applicable trials and seniors above 65 have 546 studies available."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation Comparing Tau PET Radiotracers, [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in Subjects With Normal Cognition or Prodromal to Moderate Alzheimer's Disease

2020. "Evaluation Comparing Tau PET Radiotracers, [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in Subjects With Normal Cognition or Prodromal to Moderate Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04566003.