NCT02359864

Study of Low Dose Whole Brain Irradiation in the Treatment of Alzheimer's Disease

Phase I Feasibility Study of Low Dose Whole Brain Irradiation in the Treatment of Alzheimer's Disease

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Corewell Health East · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the safety and toxicity/adverse events associated with the use of low dose fractionated whole brain irradiation in those patients who have been diagnosed with probable Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria. As a secondary goal it will establish whether or not the intervention with low dose whole brain irradiation might change the recognized progression of Alzheimer's Disease. The investigators will also collect information from the florbetaben F 18 Injection (AMYVID®) positron emission tomography (PET) Scans to determine if there is any correlation between neurocognitive/quality of life scores and changes in amyloid plaque size, number and location.

Detailed description

An initial 15 patients will be enrolled in the first treatment scheme (5 daily fractions of 2 Gy) and will be followed for 12 months after completion of treatment to assess safety and any toxicity/adverse events associated with treatment. In Arm 1 the 15 study participants will be enrolled in total at Botsford Radiation Oncology Center and William Beaumont Hospital (Royal Oak Campus). Once a total combined 15 patients are entered this Arm will be closed. The second treatment arm will not be used until the last patient in the first dose arm has completed all follow up. At that point patients #16-30 will be enrolled in the second dose arm (10 daily fractions of 2 Gy). In Arm 2 the 15 study participants will be enrolled in total at both Botsford Hospital Radiation Oncology Center and William Beaumont Hospital (Royal Oak Campus). Once a total combined 15 patients are entered this Arm will be closed. A total of 30 patients will be enrolled and each will be followed for 12 months to assess safety and toxicity/adverse events.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
RADIATION	5 daily fractions of 2 Gy	Whole Brain Irradiation to treat Alzheimer's Disease
RADIATION	10 daily fractions of 2 Gy	Whole Brain Irradiation to treat Alzheimer's Disease

Timeline

• Start date: 2019-10-01
• Primary completion: 2021-02-03
• Completion: 2021-02-03
• First posted: 2015-02-10
• Last updated: 2023-01-26
• Results posted: 2023-01-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study