Royal Oak, Michigan 48073


Purpose:

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 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 AMYViD ® PET Scans to determine if there is any correlation between neurocognitive/quality of life scores and changes in amyloid plaque size, number and location.


Study summary:

An initial 15 patients will be enrolled in the first treatment scheme (2 Gy x 5 fractions) and will be followed for 12 months after completion of treatment to assess safety and any toxicity/adverse events associated with treatment. 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). A total of 30 patients will be enrolled and each will be followed for 12 months to assess safety and toxicity/adverse events. 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. In Arm 2 the 15 study participants will be enrolled in total at both Botsford Radiation Oncology Center and William Beaumont Hospital (Royal Oak Campus). Once a total combined 15 patients are entered this Arm will be closed.


Criteria:

Inclusion Criteria: Criteria for Eligibility (All responses must be YES) 1. The patient is at least 55 years old 2. The patient is able to complete the Mini-Mental Examination and ADAS-Cog score sheets 3. No previous history of CNS Radiation 4. The patient has a Rosen Modified Hachinski Ischemic Score < 4 5. Patient has estimated survival of greater than 12 months 6. Mini Mental Status Exam Score (MMSE) is 10 - 20 7. A patient with probable diagnosis of Alzheimer's disease based on NINCDS- ADRDA criteria with MMSE scores 10 - 20 Exclusion Criteria:Criteria for Exclusion (All responses must be NO) 1. Any previous history of CNS radiation 2. The patient has a history of any oncologic disease which may mitigate the ability to receive low dose whole brain irradiation 3. Evidence of substance abuse (alcohol/or other drugs or dependence during previous 12 months (DSM-IV criteria) 4. Presence of subdural hygroma's or subdural hematomas 5. Active / Recent (within 3 months) cerebral infection/hemorrhage 6. Immuno compromise state 7. Prior history of seizure 8. Hydrocephalus 9. Dermatological skin disease of the scalp 10. Patient taking Alzheimer's medication (Exelon, Aricept, Namenda, Reminyl or Epixa)


NCT ID:

NCT02359864


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Royal Oak, Michigan 48073
United States

James Fontanesi, MD
Phone: 248-471-8120
Email: jfonatnesi@comcast.net

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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