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

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.

Inclusion Criteria:

Criteria for Eligibility (All responses must be YES)

Inclusion Criteria:

Patients must meet all eligibility criteria to be included in the study:

1. Must be 55 years of age or older

2. Patient must meet NINCDS-ADRDA criteria for Alzheimer's Disease

3. Patient must be able to complete Mini-Mental Examination (MMSE) and ADAS-Cog Score
Sheets

4. Patient has a Rosen Modified Hachinski Ischemic Score of less than or equal to 4

5. Patient has a MMSE score of between 10-20

6. Patient has estimated survival of greater than 12 months

7. Patient or legally authorized representative must be able to give consent

Exclusion Criteria:

Patients will be excluded from the study if they meet any of the following criteria:

1. The patient has a history of cancer except non-melanoma skin cancer

2. Patient is taking anti-epileptic medication.

3. Dermatological skin disease of the scalp

4. Patient taking Alzheimer medication, i.e. Exelon, Aricept, Namenda, Reminyl or Ebixa.

5. Current presence of a clinically significant major psychiatric disorder (e.g. major
depressive disorder, bipolar disorder, schizophrenia, etc., according to the
Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV))

6. Patient currently participating in another Clinical Trial.

7. Patient and legally authorized representative unable to give informed consent

8. Patient with history of focal neurological deficits (with the exception of vibratory
peripheral neuropathy)

9. Non-Alzheimer dementia

10. Patient has previous history of central nervous system radiation

11. Patient has evidence of substance abuse (alcohol / or other drugs of dependence)
during previous 12 months

12. History of subdural hygroma / subdural hematoma

13. History of cerebral infection / hemorrhage.

14. History that the patient is immunocompromised

15. History of seizure activity

16. History of hydrocephalus