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

NCT02769000 | Terminated Results

• 1 other identifier: HM20004955
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Evaluate Toxicity Associated With Delivery of Low Dose Fractionated Whole Brain Irradiation in Subjects With Early Alzheimer's Dementia According to ADRDA Criteria.

  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.

  48 months

Secondary Outcomes (7)

• Neurocognitive Function: Verbal Learning and Memory

  Baseline to 12 months

• Neurocognitive Function: Visuospatial Memory

  Baseline to 12 months

• Neurocognitive Function: Cognitive Function

  Baseline to 12 months

• Psychological Functioning: Depression

  Baseline to 12 months

• Psychological Functioning: Anxiety

  Baseline to 12 months

Study Arms (1)

Subjects 1-30

EXPERIMENTAL

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; Radiation: 20 GY in 10 daily fractions

Interventions

10 GY in 5 daily fractions RADIATION

Subjects 1-15 10 GY in 5 daily fractions

Subjects 1-30

20 GY in 10 daily fractions RADIATION

Subjects 16-30 20 GY in 10 daily fractions

Subjects 1-30

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Related Publications (1)

• Rogers CL, Lageman SK, Fontanesi J, Wilson GD, Boling PA, Bansal S, Karis JP, Sabbagh M, Mehta MP, Harris TJ. Low-Dose Whole Brain Radiation Therapy for Alzheimer's Dementia: Results From a Pilot Trial in Humans. Int J Radiat Oncol Biol Phys. 2023 Sep 1;117(1):87-95. doi: 10.1016/j.ijrobp.2023.03.044. Epub 2023 Mar 18.

  PMID: 36935024 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Timothy Harris, MD
• Organization: Virginia Commonwealth University

timothy.harris@vcuhealth.org

804-828-7232

Study Officials

• Timothy J Harris, M.D.

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2016
• First Posted: May 11, 2016
• Study Start: May 1, 2016
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: December 16, 2021
• Results First Posted: December 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)