A study comparing different tools for looking at the brain in people with Alzheimer’s disease: tau radiotracers for brain imaging with Positron Emission Tomography (PET)

Evaluation Comparing Two Tau PET Radiotracers, [18F]PI-2620 and [18F]GTP1, in Brains of Participants With Prodromal or Mild Alzheimer's Disease

Neurodegenerative Disorder
Alzheimer's Disease (AD)

For Medical Professional
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Basic Details

Sponsor Genentech, Inc. (A part of F. Hoffmann-La Roche Ltd., Switzerland)

Phase Phase 1

Study Identifier NCT04566003, GN42801

Condition Alzheimer Disease (AD)

Official Title Phase 1 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

Study Summary

This study aimed to better understand Alzheimer's disease and improve ways to find tau protein in the brain. People over 65 with normal brain function and those over 50 with Alzheimer's could join. Participants took memory and thinking tests, had health checks, including brain MRIs, and most importantly, had PET scans with three different radiotracers. These scans helped compare the radiotracers' effectiveness in detecting tau and beta-amyloid deposits. The radiotracers were safe to use. The main benefit was the valuable information gained, helping researchers advance in understanding and detecting Alzheimer's disease.

Eligibility Criteria

Gender

All

Age

≥50 Years & ≤ 90 Years

Healthy Volunteers

Inclusion Criteria

Cognitively normal subjects aged 65 to 90 years and prodromal to mild AD subjects aged 50 to 90 years, inclusive at the time of screening.
Prodromal to moderate AD subjects: Meet the National Institute on Aging - Alzheimer's Association (NIA-AA) core clinical criteria for mild cognitive impairment (MCI) due to AD, probable AD dementia or AD dementia
Have a Clinical Dementia Rating (CDR) score of 0 (cognitively normal) or 0.5 (prodromal to moderate AD) at screening
Have an Mini-Mental State Examination (MMSE) score 10-30 inclusive
Have Aβ PET imaging demonstrating Aβ binding based on qualitative visual read at screening or using an acceptable historical PET scan (cognitively normal subjects will be assessed with Aβ PET at screening but will not be required to demonstrate Aβ binding).
A brain MRI consistent with normal cognition or that supports a diagnosis of prodromal to moderate AD, with no evidence of other significant neurologic pathology. A previously acquired research MRI within the last 12 months may be used if deemed acceptable by the investigator and no significant clinically relevant changes have occurred since the prior MRI was obtained
The subject has an appropriate study partner capable of participating in CDR assessment and, if necessary, of accompanying the subject
For cognitively normal subjects only: History of at least one first degree relative with diagnosis of Alzheimer's disease (self-reported by the potential subject and/or confirmed by the study partner).

Exclusion Criteria

Current or prior history of any alcohol or drug abuse within the last 2 years
Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 millisievert (mSv), which would be above the acceptable annual limit established by the US Federal Guidelines
Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease
MRI evidence of cerebrovascular disease, infectious disease, space-occupying lesions, normal pressure hydrocephalus, or other central nervous system (CNS) disease
Implants that have not been certified for MRI or history of claustrophobia in MRI, unless an acceptable previously acquired research MRI is available

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

Results Disclaimer

What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.

A study comparing different tools for looking at the brain in people with Alzheimer’s disease: tau radiotracers for brain imaging with Positron Emission Tomography (PET)

Basic Details

Study Summary

Eligibility Criteria

What is Clinical Research?

Study results

LPS GN42801 Final Results September 2024 English (PDF, 0.2 MB)

LPS GN42801 Final Results September 2024 USA Spanish (PDF, 0.3 MB)

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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A study comparing different tools for looking at the brain in people with Alzheimer’s disease: tau radiotracers for brain imaging with Positron Emission Tomography (PET)

For the latest version of this information please go to www.forpatients.roche.com