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Low Dose RT to Reduce Cerebral Amyloidosis in Early Alzheimer's

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02769000
Recruitment Status : Terminated (The study was suspended in March of 2020 due to COVID. Rather than reopen the study, the decision was made to terminate it in July of 2021.)
First Posted : May 11, 2016
Results First Posted : December 16, 2021
Last Update Posted : December 16, 2021
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
Evaluate safety and toxicity/adverse events associated with delivery of low dose whole brain irradiation in patients with early Alzheimer's dementia 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 stabilizes or decreases cerebral amyloid deposits and whether these correlate with the recognized progression of Alzheimer's dementia. The investigators will also collect information from the FDG and 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Radiation: 10 GY in 5 daily fractions Radiation: 20 GY in 10 daily fractions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IIa Trial of Low Dose Radiation THerapy to Reduce Cerebral Amyloidosis in Early Alzheimer's Dementia
Study Start Date : May 2016
Actual Primary Completion Date : March 15, 2019
Actual Study Completion Date : March 15, 2019


Arm Intervention/treatment
Experimental: Subjects 1-30
15 subjects in each RT dose schedule 10 GY in 5 daily fractions 20 GY in 10 daily fractions
Radiation: 10 GY in 5 daily fractions
Subjects 1-15 10 GY in 5 daily fractions

Radiation: 20 GY in 10 daily fractions
Subjects 16-30 20 GY in 10 daily fractions




Primary Outcome Measures :
  1. Evaluate Toxicity Associated With Delivery of Low Dose Fractionated Whole Brain Irradiation in Subjects With Early Alzheimer's Dementia According to ADRDA Criteria. [ Time Frame: 48 months ]
    Evaluate the toxicity associated with the delivery of low dose fractionated whole brain irradiation in subjects with early Alzheimer's dementia using the CTCAE toxicity grading system. The scale is 0 - 5 with 0 being no toxicity and 5 being fatal.


Secondary Outcome Measures :
  1. Neurocognitive Function: Verbal Learning and Memory [ Time Frame: Baseline to 12 months ]
    Patients will complete the Hopkins Verbal Learning Test-Revised (HVLT-R) which is a paper and pencil assessment. Overall scores will be reported. Scores range from 0 to 26 with higher scores indicating better functioning.

  2. Neurocognitive Function: Visuospatial Memory [ Time Frame: Baseline to 12 months ]
    Patients will complete the Brief Visuospatial Memory Test-revised which is a paper and pencil assessment. Overall scores will be reported. Scores range from 0 to 36 with higher scores indicating better functioning.

  3. Neurocognitive Function: Cognitive Function [ Time Frame: Baseline to 12 months ]
    Patients will complete the Mini-Mental State Exam (MMSE) which is an interview style assessment. Overall scores will be reported. Scores range from 0 to 30 with higher scores indicating better functioning.

  4. Psychological Functioning: Depression [ Time Frame: Baseline to 12 months ]
    Patients will complete the PHQ-9 (Patient Health Questionnaire-9) which is an interview style assessment. Overall scores will be reported. Scores range from 0 to 27 with lower scores indicting lower depression.

  5. Psychological Functioning: Anxiety [ Time Frame: Baseline to 12 months ]
    Patients will complete the GAD-7 (General Anxiety Disorder-7) which is an interview style assessment. Overall scores will be reported. Scores range from 0 to 21 with lower scores indicating lower levels of anxiety.

  6. Quality of Life in Alzheimer's Disease [ Time Frame: Baseline to 12 months ]
    Patients will complete the Quality of Life in Alzheimer's Disease (QOL-AD) which is an interview style assessment. The QOL-AD is a 13-item questionnaire designed to provide both a patient and a caregiver report of the quality of life (QOL) for patients who have been diagnosed with Alzheimer Disease. Overall scores will be reported. Scores range from 13 to 52 with higher scores indicating better quality of life.

  7. Cognitive and Functional Decline [ Time Frame: Baseline to 12 months ]
    Patients will complete the Everyday Cognition (ECog) which is an interview style assessment. Overall scores will be reported. Scores range from 39 to 156 with lower scores indicating less decline in cognition.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be a native English speaker with a LAR available for consenting.
  • Able to complete neurocognitive function assessments, psychological function assessments, and QOL assessments administered at screening visit.
  • Rosen Modified Hachinski Ischemic Score less than or equal to 4
  • Estimated Survival of greater than 12 months
  • Meets the clinical definition of AD based on NINCDS-ADRDA criteria, with confirmatory F-2-DG and F-Florbetapir (Amyvid) PET scan findings
  • If on any of the following medications, must be on a stable dose for 60 days or greater: Rivastigmine, Donepezil, Memantine, Glantamine, Tacrine.

Exclusion Criteria:

  • Current or past history of any oncologic disease mitigating low dose whole brain RT
  • Evidence of substance abuse (Alcohol/or other drugs or dependences during previous 12 months (DSM-V criteria)
  • Clinically or radiographically significant evidence of stroke
  • Evidence of subdural hygromas or subdural hematomas
  • Active or recent (defined as within 3 months of screening) cerebral infection or hemorrhage
  • Any current conditions that may lead to the subject being in an immuno-compromised state
  • Any previous history of cranial radiation
  • History of seizure activity
  • History of Hydrocephalus
  • Evidence of active dermatological skin disease of the scalp (except Actinic Keratosis)
  • Evidence of clinically significant major depressive disorder identified in a psychological diagnostic interview according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-V)
  • Evidence of psychotic disorder or psychotic episode or bipolar affective disorder identified in a psychological diagnostic interview according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-V)
  • Evidence of active suicidal or homicidal ideation according to psychological diagnostic interview
  • Currently receiving other experimental treatments
  • Currently requiring full-time institutional care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02769000


Locations
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United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Timothy J Harris, M.D. Virginia Commonwealth University
  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02769000    
Other Study ID Numbers: HM20004955
First Posted: May 11, 2016    Key Record Dates
Results First Posted: December 16, 2021
Last Update Posted: December 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Alzheimer Disease
Amyloidosis
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Proteostasis Deficiencies
Metabolic Diseases