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

NCT02769000 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-12-16

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Timothy J Harris, M.D. · Virginia Commonwealth University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-03-15
Completion
2019-03-15

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02769000 on ClinicalTrials.gov