NCT02656498 is a Phase 2 clinical trial of [18F]THK-5351 in Alzheimer's Disease, sponsored by Jae Seung Kim.

Who is sponsoring NCT02656498?

NCT02656498 is sponsored by Jae Seung Kim.

What drugs are being tested in NCT02656498?

Interventions in NCT02656498: [18F]THK-5351.

What condition does NCT02656498 study?

NCT02656498 studies Alzheimer's Disease, Mild Cognitive Impairment, Neurodegenerative Diseases.

Is NCT02656498 still recruiting?

NCT02656498 is currently completed. Last updated 14 December 2020.

Last reviewed 2020-12-14 · How we verify

NCT02656498

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 14 December 2020

What this trial tests

Phase 2 trial testing [18F]THK-5351 in Alzheimer's Disease in 135 participants. Completed in 31 December 2019.

Timeline

11 January 2016

Primary endpoint
31 December 2019

31 December 2019

Quick facts

Lead sponsor	Jae Seung Kim
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	135
Start date	11 January 2016
Primary completion	31 December 2019
Estimated completion	31 December 2019
Sites	2 locations across South Korea

Drugs / interventions tested

[18F]THK-5351

Conditions studied

Alzheimer's Disease — all drugs for Alzheimer's Disease →
Mild Cognitive Impairment — all drugs for Mild Cognitive Impairment →
Neurodegenerative Diseases — all drugs for Neurodegenerative Diseases →

Sponsor

Jae Seung Kim

Who can join

Adults 40 to 80, any sex, with Alzheimer's Disease or Mild Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Combination of automated brain volumetry on MRI and quantitative tau deposition on THK-5351 PET to support diagnosis of Alzheimer's disease.
Kim M, Kim SJ, Park JE, Yun J, et al · · 2021 · cited 13× · PMID 33990649 · DOI 10.1038/s41598-021-89797-x
Predictive Scale for Amyloid PET Positivity Based on Clinical and MRI Variables in Patients with Amnestic Mild Cognitive Impairment.
Chun MY, Kim GH, Park HK, Yang DW, et al · · 2022 · cited 6× · PMID 35743503 · DOI 10.3390/jcm11123433
<sup>18</sup>F-THK5351 PET Positivity and Longitudinal Changes in Cognitive Function in β-Amyloid-Negative Amnestic Mild Cognitive Impairment.
Chun MY, Lee J, Lee J, Jeong JH, et al · · 2022 · cited 6× · PMID 35184428 · DOI 10.3349/ymj.2022.63.3.259
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.
Park JE, Yun J, Kim SJ, Shim WH, et al · · 2019 · cited 5× · PMID 31834916 · DOI 10.1371/journal.pone.0226265

Verify or expand the search:

Other trials of [18F]THK-5351

Trials testing the same drug.

NCT04572477 — The Influence of Sequential Tau Protein and Amyloid Plaque Imaging Changes on Stroke Prognosis and Cognitive Outcome · Phase 2 · unknown
NCT03112096 — A Phase I [18F]THK-5351 Positron Emission Tomography Study in Healthy Subjects and Alzheimer's Disease · Phase 1 · completed

Other recruiting trials for Alzheimer's Disease

Currently open trials in the same condition.

NCT07457138 — Lombard Cohort of Brain Health Services · recruiting
NCT07234942 — A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants Wit · Phase 1 · recruiting
NCT07479914 — Art of Memory for Cognitive Enhancement in the Monza Brain Health Service · NA · active not recruiting
NCT07214727 — A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease · Phase 1 · recruiting
NCT07105709 — Open-label Extension Study in Participants With Early Alzheimer's Disease · Phase 2 · recruiting

Other Jae Seung Kim trials

Trials by the same sponsor.

NCT03903211 — Longitudinal Changes of [18F]PI-2620 Positron Emission Tomography in Subjects With Cognitively Normal, Mild Cognitive Im · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02656498 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jae Seung Kim
Last refreshed: 14 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02656498.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing