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Alzheimer's DiseasePhase 2NCT02656498

[18F]THK-5351 Positron Emission Computed Tomography Study of Normal, Mild Cognitive Impairment, Alzheimer's Disease and Other Neurodegenerative Disease

A Phase 2 study testing [18F]THK-5351 in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Jae Seung Kim at 2 sites 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 cross-sectional and longitudinal study to evaluate the clinical utility of [18F]THK-5351 positron emission computed tomography in cognitively healthy volunteers, mild cognitive impairment (MCI), Alzheimer's disease (AD) and other neurodegenerative patients. Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
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
135 participants
Where
2 sitesSouth Korea
Study dates
11 Jan 2016to 31 Dec 2019
Phase
Phase 2
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 40 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 ≥ 40 and < 80 years of age at the Screening Visit.
  • 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 ECG within normal limits (at 90 days prior to [18F]THK-5351 positron emission computed tomography) or clinically acceptable to the investigator at screening.
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  • 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.
  • If female, not be of childbearing potential as indicated by one of the following
  • 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.
  • Each subject must be willing to provided blood samples for genotyping apolipoprotein E
  • Cognitively Healthy Subjects
  • MCI Subjects
  • AD Subjects
  • Subjects with other neurodegenerative disease

Who cannot join

  • The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below:
  • 1. General Exclusion Criteria
  • 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.
  • The patient has an abnormal physical examination or abnormal laboratory test results at the screening that are clinically significant to affect results of the research, as judged by the investigator.
  • If the patient has or is suspicious of having a hypersensitivity or allergy to [18F] THK-5351 or its derivatives.
  • The patient is pregnant, is attempting to become pregnant, or is nursing (breast-feeding) children.
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  • The patient has a history of alcoholism or drug dependency/abuse within the last 2 years before screening.
  • The patient has contraindications to undergo positron emission computed tomography 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.
  • The patient has been treated with any investigational medicinal product (IMP) within 30 days prior to the screening visit.
  • 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.
  • The patient has been receiving an anti-cholinergic drug in a regular basis within 3 months prior to the screening visit.
  • 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.

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: An Open Label, Multicenter Study for Evaluation of the Clinical Utility of [18F]THK-5351 Positron Emission Computed Tomography in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, Subjects With Alzheimer's Disease and Subjects With Other Neurodegenerative Diseases

This is a cross-sectional and longitudinal study to evaluate the clinical utility of [18F]THK-5351 positron emission computed tomography in cognitively healthy volunteers, mild cognitive impairment (MCI), Alzheimer's disease (AD) and other neurodegenerative patients.

Being tested
[18F]THK-5351
Keywords
Tau, neurodegeneration, positron emission computed tomography
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction, Neurodegenerative Diseases, 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 accumulation of abnormal tau protein in the brain

Study groups in NCT02656498
Study groupRoleWhat they receive
Cognitively Healthy SubjectsExperimentalCognitively healthy subjects will receive an IV injection, [18F]THK-5351 at baseline and also receive an IV injection, [18F]THK-5351 at 24 months.
Receives: Drug: [18F]THK-5351
MCI SubjectsExperimentalMCI Subjects will receive an IV injection, [18F]THK-5351 at baseline and also receive an IV injection, [18F]THK-5351 at 24 months.
Receives: Drug: [18F]THK-5351
AD SubjectsExperimentalAD Subjects will receive an IV injection, [18F]THK-5351 at baseline and also receive an IV injection, [18F]THK-5351 at 24 months.
Receives: Drug: [18F]THK-5351
Subjects with other neurodegenerative diseaseExperimentalSubjects with other neurodegenerative disease will receive an IV injection, [18F]THK-5351 at baseline.
Receives: Drug: [18F]THK-5351

What is being measured

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

  1. Cross-sectional [18F]THK-5351 Imaging Results

    Compare Standard uptake value ratio (SUVR) and distribution of [18F]THK-5351 in subjects with MCI, subjects with AD, subjects with other neurodegenerative disease and cognitively healthy individuals.

    Measured: 50-70 minutes post injection

  2. Assess the rate of change of tau deposition as measured by [18F]THK-5351 uptake (SUVR) over time

    Compare Standard uptake value ratio (SUVR) and distribution of [18F]THK-5351 in subjects with MCI, subjects with AD, subjects with other neurodegenerative disease and cognitively healthy individuals.

    Measured: 24 months

Secondary outcomes (4)

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

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

    Measured: 50-70 minutes post-injection

  2. Correlation between standard uptake value ratio (SUVR) of [18F]THK-5351 positron emission computed tomography and indices of structural MRI

    We will evaluate correlation between standard uptake value ratio (SUVR) [18F]THK-5351 positron emission computed tomography and indices of structural MRI including cortical thickness, hippocampal atrophy.

    Measured: 50-70 minutes post-injection

  3. Correlation between standard uptake value ratio (SUVR) of [18F]THK-5351 positron emission computed tomography and indices of functional MRI

    We will evaluate correlation between standard uptake value ratio (SUVR) [18F]THK-5351 positron emission computed tomography and indices of functional MRI derived from diffusion tensor imaging and resting state functional MRI.

    Measured: 50-70 minutes post-injection

  4. Correlation between standard uptake value ratios (SUVR) and distribution of [18F]THK-5351 positron emission computed tomography and amyloid positron emission computed tomography

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

    Measured: 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 posted15 Jan 2016 (estimated)
  2. Study start11 Jan 2016
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 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 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02656498
Sponsor's protocol ID
THK-15002
Status last verified
Dec 2020
First submitted
12 Jan 2016
Last updated
14 Dec 2020
Results posted
No
Data monitoring committee
No

Publications

  • Chun MY, Lee J, Jeong JH, Roh JH, Oh SJ, Oh M, Oh JS, Kim JS, Moon SH, Woo SY, Kim YJ, Choe YS, Kim HJ, Na DL, Jang H, Seo SW. 18F-THK5351 PET Positivity and Longitudinal Changes in Cognitive Function in beta-Amyloid-Negative Amnestic Mild Cognitive Impairment. Yonsei Med J. 2022 Mar;63(3):259-264. doi: 10.3349/ymj.2022.63.3.259.

    PubMed 35184428

  • Park JE, Yun J, Kim SJ, Shim WH, Oh JS, Oh M, Roh JH, Seo SW, Oh SJ, Kim JS. Intra-individual correlations between quantitative THK-5351 PET and MRI-derived cortical volume in Alzheimer's disease differ according to disease severity and amyloid positivity. PLoS One. 2019 Dec 13;14(12):e0226265. doi: 10.1371/journal.pone.0226265. eCollection 2019.

    PubMed 31834916

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [18F]THK-5351 in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Jae Seung Kim at 2 sites 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 14 inclusion and 12 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 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Cross-sectional [18F]THK-5351 Imaging Results (time frame: 50-70 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 NCT02656498, which also lists 2 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 14 Dec 2020.

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