Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants

Alzheimer's Disease Clinical Trial

Official title:

Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Patients With Prodromal, Mild, and Moderate Alzheimer's Disease Compared to Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02640092
• Other study ID #: GN30009
• Secondary ID: G0097
• Status: Completed
• Phase: Phase 1
• Start date: December 23, 2015
• Est. completion date: June 11, 2019

Study information

• Verified date: December 2019
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, longitudinal observational study evaluating the imaging characteristics of the tau positron-emission tomography (PET) radioligand [18F] Genentech Tau Probe 1 (GTP1) in the brain of participants with prodromal, mild, and moderate Alzheimer's disease (AD) compared to healthy participants. The overall goal of this protocol is to evaluate the longitudinal change in tau burden using [18F]GTP1, a tau targeted radiopharmaceutical.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 11, 2019
• Est. primary completion date: June 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

For All Participants:

• Availability of a study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to accompany the participant and provide information at visits

For Healthy Participants:

• Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline [18F]GTP1 imaging visit

• Have no cognitive complaint

• Have a Clinical Dementia Rating Scale (CDR) global score = 0

• Have a Mini-Mental State Examination (MMSE) score of 28-30

For Participants With a Diagnosis of AD:

• Participants with mild or moderate AD must meet National Institute on Aging - Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia, with an amnestic presentation

• Participants with prodromal AD must meet NIA-AA core clinical criteria for mild cognitive impairment (MCI)

• Have screening [18F]florbetapir PET imaging demonstrating amyloid binding based on qualitative visual read

• A brain MRI consistent with a diagnosis of AD, with no evidence of non-AD disease to account for dementia or MRI exclusion criteria

• Medications taken for symptomatic treatment of AD must remain stable for at least 30 days prior to screening visit

• Satisfy one of the following subgroups: Approximately 20 prodromal AD (MMSE 24-30, CDR = 0.5); Approximately 20 mild AD (MMSE 22-30, CDR = 0.5 or 1); Approximately 20 moderate AD (MMSE 16-21, CDR = 0.5 or 1 or 2)

Exclusion Criteria:

• Current or prior history of any drug or alcohol abuse

• Participants with any significant psychiatric, neurological, or unstable medical disorder expected to interfere with the study

• Participants unable to undergo MRI and PET scan

• For participants contributing CSF samples, any contraindication to lumbar puncture

• Prior participation in other research protocols or clinical care in the last year such a radiation exposure combined with that from the present study exceeds an effective dose of 50 millisievert (mSV), the allowable annual limit for research participants as stipulated by the Food and Drug Administration (FDA)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• [18F]GTP1
Participants will receive [18F]GTP1 as per the schedule specified in the arm description.

Locations

Country	Name	City	State
United States	Lehigh Center Clinical Research	Allentown	Pennsylvania
United States	Emory University	Atlanta	Georgia
United States	Acadia Clinical Research; Dr. Henderson's Office	Bangor	Maine
United States	NeuroStudies.net, LLC	Decatur	Georgia
United States	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	Neuropsychiatric Research; Center of Southwest Florida	Fort Myers	Florida
United States	Advanced Medical Research	Maumee	Ohio
United States	Miami Jewish Health Systems	Miami	Florida
United States	NeuroCognitive Institute	Mount Arlington	New Jersey
United States	Molecular NeuroImaging	New Haven	Connecticut
United States	Bioclinica Research	Orlando	Florida
United States	Donald S. Marks, M.D., P.C.; Medical Center	Plymouth	Massachusetts
United States	Butler Hospital	Providence	Rhode Island
United States	Alzheimers Disease Center	Quincy	Massachusetts
United States	KI Health Partners, LLC; New England Institute for Clinical Research	Stamford	Connecticut
United States	Bio Behavioral Health	Toms River	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1		From Baseline to 18 months
Secondary	Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)13		From Baseline to 18 months
Secondary	Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Volumetric Magnetic Resonance Imaging (MRI) Measures		From Baseline to 18 months
Secondary	Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Cerebrospinal Fluid (CSF) Markers		From Baseline to 18 months
Secondary	Percentage of Participants With Adverse Events (AEs)		From Baseline to 18 months
Secondary	Test-Retest Variability Based on [18F]GTP1 PET Scans		From date of test scan to 7-21 days after test scan