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Alzheimer DiseasePhase 1NCT03112096

A Phase I [18F]THK-5351 Positron Emission Tomography Study in Healthy Subjects and Alzheimer's Disease

A Phase 1 study testing [18F]THK-5351 in people with Alzheimer Disease, run by Asan Foundation at 1 site in South Korea.

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 a study to evaluate biodistribution, pharmacokinetics and safety of [18F]THK-5351 positron emission computed tomography in Cognitively Healthy Subjects and Patients with Alzheimer's Disease. Read more about this study

Who is it for?
Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
[18F]THK-5351
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteSouth Korea
Study dates
17 May 2017to 31 Aug 2018
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 20 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • General Subject Inclusion Criteria
  • In order to be eligible for participation in this trial, the subject must:
  • Be able to read at a 6th grade level or equivalent, (as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation.)
  • Be able to speak, read, hear, and understand the language of the trial staff, and the informed consent form, and possess the ability to respond verbally to questions, follow instructions, and complete questionnaires and detailed neuropsychological test.
  • Have results of clinical laboratory tests/physical examination, vital signs, and Electrocardiogram within normal limits (at 45 days prior to [18F]THK-5351 Positron Emission Tomography scan ) or clinically acceptable to the investigator at screening.
  • Be able to possess the ability to respond verbally to questions, follow instructions, and underwent research assessment, including brain images based on the investigator's judgment. Each subject is also able and willing to adhere visit schedules.
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  • If female, not be of childbearing potential as indicated by one of the following
  • has reached natural menopause, defined as ≥ 24 months of spontaneous amenorrhea or
  • has had a hysterectomy; or
  • has had a bilateral oophorectomy (with or without a hysterectomy) and more than 6 weeks have passed since the surgery.
  • Each subject (or legal representative) must sign the informed consent form in accordance with local requirements after the scope and nature of the investigation have been explained to them, and before screening assessments.
  • Normal Subject Inclusion Criteria
  • <!-- -->
  • . Be ≥ 20 years of age at the screening visit
  • Each subject must not report a history of memory decline with gradual onset and slow progression, that is either corroborated by an informant who knows the subject well or is documented in medical records. Each subject must have general cognitive function and activities of daily living sufficiently intact, based on clinical assessment, so as not to meet criteria for mild AD dementia (based on DSM-IV-TR(Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) and NINCDS-ADRDA(National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association) criteria).
  • Each subject must have results of Korean-Mini Mental State Exam (K-MMSE) at screening that is ≥1.5 SD above the appropriate population mean, corrected age and education.
  • Each subject must not have objective impairment in memory at screening that is ≥1.5 SD above the appropriate population mean, corrected age and education, as measured by the Seoul Verbal Learning Test (SVLT) delayed recall score of the Seoul Neuropsychological Screening Battery (SNSB)-Ⅱ.
  • Each subject must have normal level of general cognitive function and activities of daily living sufficiently intact, that is 0 score as measured by the Clinical Dementia Rating (CDR).
  • Each subject must have an MRI scan obtained at screening that supports diagnosing the current status of normal cognition. The MRI for research must be consistent and sufficient in quality enough to analyze volume of interest (VOI) with partial volume correction (Detailed protocol is described in the MRI scanning manual).
  • Each subject must be willing to provided blood samples for genotyping apolipoprotein E.
  • Alzheimer's Disease Inclusion Criteria
  • <!-- -->
  • Be ≥ 50 and < 80 years of age at the Screening Visit.
  • Each subject must have general cognitive function and activities of daily living impairment, based on clinical assessment, so as to meet criteria for AD dementia (based on DSM-IV-TR and NINCDS-ADRDA criteria).
  • Each subject's K-MMSE score ranges 15-26 and CDR 0.5, 1 or 2.
  • Each subject must have a Rosen-modified Hachinski Ischemia Score ≤ 4 at Screening.
  • Each subject must have a reliable and competent trial partner/informant who must have a close relationship with the subject, and can be accompanied at all visits in this study.
  • Each subject must have an MRI scan obtained at screening that supports diagnosing Alzheimer's disease. The MRI for research must be consistent and sufficient in quality enough to analyze volume of interest (VOI) with partial volume correction (Detailed protocol is described in the MRI scanning manual).
  • If receiving some medications, be on a stable dose for at least the 4 weeks before performing THK5351 PET scan, and the subject must be willing to remain on the same dose for the duration of the trial.
  • Each subject must be willing to provided blood samples for genotyping ApoE.
  • Each subject must shows positive in amyloid PET scan.

Who cannot join

  • The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below:
  • General Exclusion Criteria 1. Based on the investigators' judgement, if the patient is not capable of communicating with the site personnel, if the patient is not proficient in the language in which the psychometric tests will be completed, or if the patient is not sufficient for compliance with the study procedures.
  • 2. The patient has an abnormal physical examination, abnormal laboratory test or electrocardiography results at the screening that are clinically significant to affect results of the research, as judged by the investigator.
  • 3. If the patient has or is suspicious of having a hypersensitivity or allergy to [18F] THK-5351 or its derivatives.
  • 4. The patient is pregnant, is attempting to become pregnant, or is nursing (breast-feeding) children.
  • 5. The patient has a history of alcoholism or drug dependency/abuse within the last 2 years before screening.
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  • 6. The patient has contraindications to undergo PET or MRI, which include but are not restricted to the examples below: claustrophobia, cardiac pacemaker, metal devices around the eye or spinal cord, cochlear implant, etc.) at the screening visit.
  • 7. The patient has been treated with any investigational medicinal product (IMP) within 30 days prior to the screening visit.
  • 8. The patient has been tested positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), HIV Antibody, or syphilis serum test at the screening visit.
  • 9. The patient has been receiving an anti-cholinergic drug in a regular basis within 3 months prior to the screening visit.
  • 10. The patient has evidence of a clinically relevant neurological disorders other than the disease being studied (i.e., prodromal AD) at screening, including but not limited to: territorial cerebral infarction, intracranial hemorrhage, multiple sclerosis, neurosyphilis, mental retardation, hypoxic encephalopathy, major head trauma with loss of consciousness that led to persistent cognitive deficits.
  • 11. The patients has disorders related to blood coagulation which could be inappropriate for arterial or venous sampling.
  • Normal Subject Exclusion Criteria 1. The patient has evidence of a clinically significant medical disorder, neurological disorder, has an abnormal physical examination or abnormal laboratory evaluations from the screening visit, or has other abnormal findings that are clinically significant, as judged by the investigator.
  • 2. The patient has more than one direct family members who were diagnosed with Alzheimer's disease.
  • Alzheimer's Disease Exclusion Criteria
  • The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD including but not limited to stroke, traumatic brain injury, non-Alzheimer tauopathy, Parkinson's disease, or has evidence of a clinically relevant or unstable psychiatric disorders, including but not limited to major depression, schizophrenia, or bipolar disorder.
  • The patient has more than two direct family members who were diagnosed with Alzheimer's disease.
  • The patient has a stroke or an evidence of significant cerebrovascular disease from screening imaging scan that is clinically important in the investigator's opinion.
  • The patient has received any of the treatments targeting tau protein prior to [18F]THK-5351 PET scan.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

About this study

Official title: A Phase I [18F]THK-5351 Positron Emission Computed Tomography Study of Biodistribution, Pharmacokinetics and Safety in Cognitively Healthy Subjects and Patients With Alzheimer's Disease

This is a study to evaluate biodistribution, pharmacokinetics and safety of [18F]THK-5351 positron emission computed tomography in Cognitively Healthy Subjects and Patients with Alzheimer's Disease.

Read the detailed description

This is a study to evaluate biodistribution, pharmacokinetics and safety of [18F]THK-5351 positron emission computed tomography. Ten cognitively healthy subjects and 10 patients with Alzheimer's Disease will be enrolled. The primary outcome measures are to evaluate pharmacokinetics of [18F]THK-5351 Positron Emission Tomography imaging . Tracer biodistribution will be evaluated by global and regional standardized uptake value ratio of [18F]THK-5351 in the brain. Safety. For safety assessment, a physical examination, Electrocardiogram and vital signs will be performed at baseline and at the completion of all imaging to assess for interval change.

Being tested
[18F]THK-5351
Keywords
Tau, neurodegeneration, positron emission tomography
Medical subject headings
Alzheimer Disease, Pick Disease of the Brain, Nerve Degeneration

What participants receive

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

  • [18F]THK-5351Drug

    Also called FluoroTau

    Imaging for evaluating the biodistribution, pharmacokinetics and safety of abnormal tau protein in the brain

Study groups in NCT03112096
Study groupRoleWhat they receive
Cognitively Healthy SubjectsExperimentalCognitively healthy subjects will receive an IV injection, [18F]THK-5351 injection
Receives: Drug: [18F]THK-5351
Alzheimer's Disease SubjectsExperimentalCognitively healthy subjects will receive an IV injection, [18F]THK-5351 injection
Receives: Drug: [18F]THK-5351

What is being measured

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

  1. Pharmacokinetics: Maximum Serum Concentration (Cmax) of [18F]THK-5351

    Compare time activity curve and calculate maximum serum concentration (Cmax) of each region of interest of [18F]THK-5351 positron emission computed tomography in cognitively healthy subjects and patients with Alzheimer's disease

    Measured: 0-90 minutes post injection

  2. Assess global and regional tau deposition as measured by standard uptake value ratio (SUVR) of [18F]THK-5351

    Compare Standard uptake value ratio (SUVR) and distribution of [18F]THK-5351 in cognitively healthy subjects and patients with Alzheimer's disease

    Measured: 0-90 minutes post injection or 50-70 minutes post injection

Secondary outcomes (4)

  1. Correlation between standard uptake value ratio (SUVR) and distribution volume of ratio(DVR) of [18F]THK-5351 positron emission computed tomography

    We will evaluate correlation between standard uptake value ratio (SUVR) and distribution volume of ratio(DVR) of[18F]THK-5351 positron emission computed tomography

    Measured: 0-90 minutes post injection or 50-70 minutes post injection

  2. Optimal scanning time for brain imaging using F-18 THK-5351.

    PET data will be acquired during a 90-min dynamic brain PET scan and will be started simultaneously with the injection of 10mCi of F-18 THK-5351. Reconstruction of PET imaging with several time frame will be compared.

    Measured: 0-90 minutes post injection

  3. Concentrations of metabolite in plasma of [18F]THK-5351

    Plasma metabolite concentrations [18F]THK-5351 will be assessed.

    Measured: 0-90 minutes post injection or 50-70 minutes post injection

  4. Number of participants with treatment related adverse events as a measure of safety

    For safety assessment, a physical examination, EKG and vital signs will be performed at baseline and at the completion of all imaging to assess for interval change.

    Measured: 0-90 minutes post injection or 50-70 minutes post injection

Timeline

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

  1. First posted13 Apr 2017
  2. Study start17 May 2017
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03112096
Sponsor's protocol ID
THK-15001
Status last verified
Dec 2020
First submitted
26 Mar 2017
Last updated
14 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]THK-5351 in people with Alzheimer Disease, run by Asan Foundation at 1 site in South Korea.

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 31 inclusion and 19 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 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

Pharmacokinetics: Maximum Serum Concentration (Cmax) of [18F]THK-5351 (time frame: 0-90 minutes post injection). The study lists 2 primary outcomes in all. 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 NCT03112096.

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 14 Dec 2020.

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