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Alzheimer's DiseasePhase 1NCT02640092

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

A Phase 1 study testing [18F]GTP1 in people with Alzheimer's Disease, run by Genentech, Inc. at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease
What is being tested?
[18F]GTP1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
16 sitesUnited States
Study dates
23 Dec 2015to 11 Jun 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 14Show fewer
  • 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)

Who cannot join

  • 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)

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Lehigh Center Clinical Research

    Allentown, Pennsylvania, 18104

  • Emory University

    Atlanta, Georgia, 30303

  • Acadia Clinical Research; Dr. Henderson's Office

    Bangor, Maine, 04401

  • NeuroStudies.net, LLC

    Decatur, Georgia, 30033

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Neuropsychiatric Research; Center of Southwest Florida

    Fort Myers, Florida, 33912

  • Advanced Medical Research

    Maumee, Ohio, 43537

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • NeuroCognitive Institute

    Mount Arlington, New Jersey, 07856

  • Molecular NeuroImaging

    New Haven, Connecticut, 06510

  • Bioclinica Research

    Orlando, Florida, 32806

  • Donald S. Marks, M.D., P.C.; Medical Center

    Plymouth, Massachusetts, 02360

  • Butler Hospital

    Providence, Rhode Island, 02906

  • Alzheimers Disease Center

    Quincy, Massachusetts, 02169

  • KI Health Partners, LLC; New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

Other trials in United States

About this study

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

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.

Being tested
[18F]GTP1
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]GTP1Drug

    Also called [18F]G02941054, [18F]MNI-798, [18F]RO6880276

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

Study groups in NCT02640092
Study groupRoleWhat they receive
[18F]GTP1ExperimentalParticipants will complete [18F]GTP1 PET imaging at four time points: Baseline, 6 months, 12 months and 18 months. For each [18F]GTP1 imaging session, the following procedure will be performed: a catheter will be placed for intravenous (IV) administration of [18F]GTP1. Participants will receive an IV bolus injection of up to 370 megabecquerel (MBq) (10 millicurie [mCi]) of [18F]GTP1.
Receives: Drug: [18F]GTP1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1

    Measured: From Baseline to 18 months

Secondary outcomes (5)

  1. Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)13

    Measured: From Baseline to 18 months

  2. Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Volumetric Magnetic Resonance Imaging (MRI) Measures

    Measured: From Baseline to 18 months

  3. Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Cerebrospinal Fluid (CSF) Markers

    Measured: From Baseline to 18 months

  4. Percentage of Participants With Adverse Events (AEs)

    Measured: From Baseline to 18 months

  5. Test-Retest Variability Based on [18F]GTP1 PET Scans

    Measured: From date of test scan to 7-21 days after test scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2015 (estimated)
  2. Study start23 Dec 2015
  3. Primary completion11 Jun 2019
  4. Study completion11 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02640092
Sponsor's protocol ID
GN30009
Other IDs
G0097
Status last verified
Dec 2019
First submitted
15 Dec 2015
Last updated
23 Dec 2019
Results posted
No

Publications

  • Sanabria Bohorquez SM, Baker S, Manser PT, Tonietto M, Galli C, Wildsmith KR, Zou Y, Kerchner GA, Weimer R, Teng E. Evaluation of partial volume correction and analysis of longitudinal [18F]GTP1 tau PET imaging in Alzheimer's disease using linear mixed-effects models. Front Neuroimaging. 2024 Mar 28;3:1355402. doi: 10.3389/fnimg.2024.1355402. eCollection 2024.

    PubMed 38606196

  • Teng E, Manser PT, Sanabria Bohorquez S, Wildsmith KR, Pickthorn K, Baker SL, Ward M, Kerchner GA, Weimer RM. Baseline [18F]GTP1 tau PET imaging is associated with subsequent cognitive decline in Alzheimer's disease. Alzheimers Res Ther. 2021 Dec 1;13(1):196. doi: 10.1186/s13195-021-00937-x.

    PubMed 34852837

  • Blennow K, Chen C, Cicognola C, Wildsmith KR, Manser PT, Bohorquez SMS, Zhang Z, Xie B, Peng J, Hansson O, Kvartsberg H, Portelius E, Zetterberg H, Lashley T, Brinkmalm G, Kerchner GA, Weimer RM, Ye K, Hoglund K. Cerebrospinal fluid tau fragment correlates with tau PET: a candidate biomarker for tangle pathology. Brain. 2020 Feb 1;143(2):650-660. doi: 10.1093/brain/awz346.

    PubMed 31834365

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]GTP1 in people with Alzheimer's Disease, run by Genentech, Inc. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1 (time frame: From Baseline to 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02640092, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.

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