Low-Dose Radiotherapy for Alzheimer's Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorEvan Thomas
About this trial
To evaluate the safety and tolerability of low-dose whole brain radiotherapy (WBRT) delivered as an induction course of 0.3 Gy × 10 fractions (3.0 Gy total) followed by 12 months of monthly maintenance LDRT (0.3 Gy × 10 fractions; 3.0 Gy total) in patients with Alzheimer's disease or dementia with inflammatory components
Eligibility criteria
Qualifiers
Age ≥50 years at time of enrollment
Externally confirmed diagnosis by a neurologist or geriatric psychiatrist (at Renaissance Institute, collaborating neurologist Dr. Sherif Makar, MD of Charis Neurology is available for diagnostic consultation) of one of the following: a. Alzheimer's disease (per NIA-AA 2011 or 2018 criteria) b. Frontotemporal dementia with documented inflammatory features c. Dementia with Lewy bodies with elevated inflammatory CSF markers d. Other neurodegenerative dementia with confirmed inflammatory component (elevated CSF IL-6, IL-1β, or TNF-α; or neuroimaging evidence of neuroinflammation)
MoCA score 10-25 at baseline screening (moderate-to-mild cognitive impairment range)
Karnofsky Performance Status (KPS) ≥60 or ECOG Performance Status ≤2
Disqualifiers
Prior whole brain or partial brain radiotherapy of any dose at any time
Active systemic malignancy requiring concurrent oncologic treatment
Implanted device contraindicated with radiation therapy (pacemaker, cochlear implant, deep brain stimulator, or equivalent)
Brain MRI demonstrating any of the following: (a) more than 4 cerebral microhemorrhages on susceptibility-weighted imaging (SWI) or gradient echo (GRE) sequences; (b) more than 1 area of superficial cortical siderosis; (c) severe white matter disease (Fazekas grade 3); or (d) any macrohemorrhage or hemosiderin-stained lesion >10 mm. These thresholds are adapted from established AD trial imaging exclusion criteria to minimize enrollment of patients with advanced cerebrovascular disease or pre-existing hemorrhagic risk factors.
Trial design
Treatments tested in this trial
- Low Dose Radiation Therapy
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Evan Thomas
Lead sponsor
Renaissance Institute of Precision Oncology and Radiosurgery
Sponsor institution
Source ClinicalTrials.gov