Study of Low Dose Whole Brain Irradiation in the Treatment of Alzheimer's Disease
Stopped early · Not applicable
Conditions studied: Alzheimer's Disease
In brief
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.
Key facts
- Study ID
- NCT02359864
- Run by
- Corewell Health East
- People needed
- 2
- Starts
- 2019-10-01
- Expected to finish
- 2021-02-03
- Last updated by the study team
- 2023-01-26
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Criteria for Eligibility (All responses must be YES)
- Inclusion Criteria:
- Patients must meet all eligibility criteria to be included in the study:
- Must be 55 years of age or older
- Patient must meet NINCDS-ADRDA criteria for Alzheimer's Disease
- Patient must be able to complete Mini-Mental Examination (MMSE) and Alzheimer's Disease Assessment Scale - Cognitive (ADAS-Cog) questionnaire Score Sheets
- Patient has a Rosen Modified Hachinski Ischemic Score of less than or equal to 4
- Patient has a MMSE score of between 10-20
- Patient has estimated survival of greater than 12 months
- Patient or legally authorized representative must be able to give consent
You may not qualify if…
- Patients will be excluded from the study if they meet any of the following criteria:
- The patient has a history of cancer except non-melanoma skin cancer
- Patient is taking anti-epileptic medication.
- Dermatological skin disease of the scalp
- Patient taking Alzheimer medication within the last 3 months, i.e. Exelon, Aricept, Namenda, Reminyl or Ebixa.
- 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))
- Patient currently participating in another Clinical Trial.
- Patient and legally authorized representative unable to give informed consent
- Patient with history of focal neurological deficits (with the exception of vibratory peripheral neuropathy)
- Non-Alzheimer dementia
- Patient has previous history of central nervous system radiation
- Patient has evidence of substance abuse (alcohol / or other drugs of dependence) during previous 12 months
- History of subdural hygroma / subdural hematoma
- History of cerebral infection / hemorrhage.
- History that the patient is immunocompromised
- History of seizure activity
- History of hydrocephalus
Where it is running
- Beaumont Health — Farmington Hills, Michigan, United States
- Beaumont Health — Royal Oak, Michigan, United States
Full record on ClinicalTrials.gov
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