Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-28 @ 6:29 AM
Study NCT ID:
NCT05635968
Status:
COMPLETED
Last Update Posted:
2025-08-27
First Post:
2022-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Trial of Low Dose Irradiation for Alzheimer's Disease
Sponsor:
Kyung Hee University Hospital at Gangdong
Organization:
Study Overview
Official Title:
The Multicenter Phase II Clinical Trial for Evaluation of Safety and Efficacy Using Low Dose Irradiation With Alzheimer's Disease
Status:
COMPLETED
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LDRT-AD-02
Brief Summary:
This is a phase II, multicenter, prospective, randomized controlled trial to treat patients with Alzheimer's disease (AD) using low-dose irradiation (LDIR). This study aims to evaluate the safety and efficacy of LDIR to whole brain in patients with AD and to determine the potentially applicable radiation dose.
Detailed Description:
Screening tests, cognitive function tests, brain MRI, and amyloid PET are performed on subjects who voluntarily consent in writing to participate in the trial to determine whether they meet the inclusion/exclusion criteria. Randomization is assigned to eligible subjects. The experimental groups are irradiated six times for 3 weeks according to the radiation dose determined for each group, and the control group is irradiated with sham radiation. The patients assigned to the experimental group receive whole brain irradiation with 6 MV energy using a linear accelerator. In the experimental group (1), 20 patients receive 4cGy x 6 times, a total of 24 cGy of irradiation. In the experimental group (2), 20 patients receive 50 cGy x 6 times, a total of 300 cGy of irradiation. All experimental groups and control group visit the hospital about 1, 6, and 12 months after irradiation to evaluate efficacy and safety.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: