Study of Low Dose Whole Brain Irradiation in the Treatment of Alzheimer's Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
Summary
- Conditions
- Alzheimer's Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Single Group AssignmentIntervention Model Description: Single group pilot study of radiation treatment. The two arms are sequential dose increase.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 55 years and 125 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT02359864
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: James Fontanesi, MD William Beaumont Hospitals
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