RecruitingAlzheimer DementiaDementiaAlzheimer Dementia (AD)
Low-Dose Radiotherapy for Alzheimer's Disease
Eligible age
50+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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
Sponsor: Evan Thomas
You may qualify if…
- ✓ 1. Age ≥50 years at time of enrollment
- ✓ 2. 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)
- ✓ 3. MoCA score 10-25 at baseline screening (moderate-to-mild cognitive impairment range)
- ✓ 4. Karnofsky Performance Status (KPS) ≥60 or ECOG Performance Status ≤2
- ✓ 5. Medically stable and capable of receiving radiation therapy as assessed by the treating radiation oncologist
- ✓ 6. Reliable caregiver or informant able to accompany the patient to ≥80% of scheduled visits
- ✓ 7. Written informed consent from patient (if decision-making capacity is preserved) and/or legally authorized representative (LAR); caregiver co-consent required
- ✓ 8. Life expectancy ≥18 months in the opinion of the treating physician
You may not qualify if…
- ✕ 1. Prior whole brain or partial brain radiotherapy of any dose at any time
- ✕ 2. Active systemic malignancy requiring concurrent oncologic treatment
- ✕ 3. Implanted device contraindicated with radiation therapy (pacemaker, cochlear implant, deep brain stimulator, or equivalent)
- ✕ 4. 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.
- ✕ 5. Known active cerebral amyloid angiopathy-related inflammation (CAA-ri) or amyloid-related beta-angiitis (ABRA), whether confirmed by biopsy, CSF analysis, or neuroimaging features consistent with active leptomeningeal or parenchymal amyloid-related inflammation
- ✕ 6. Active autoimmune encephalitis in acute phase (patients in stable chronic phase are eligible)
- ✕ 7. Uncontrolled systemic infection or active sepsis at enrollment
- ✕ 8. Severe psychiatric comorbidity (active psychosis, active suicidal ideation) impairing protocol compliance or safety assessment
Where it's recruiting
Florida
Winter Park
Source: ClinicalTrials.gov · NCT07693140 · last updated 2026-07-09