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Recruiting Phase 1 / Phase 2

Low-Dose Radiotherapy for Alzheimer's Disease

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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

Condition
Alzheimer Dementia, Dementia, Alzheimer Dementia (AD), Alzheimer, Alzheimer s Disease
Tested
Low Dose Radiation Therapy
Sponsor
Evan Thomas

Who can join

Age
50 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 17

  • Minimum age: 50 years
  • Study condition: Alzheimer Dementia, Dementia, Alzheimer Dementia (AD), Alzheimer, Alzheimer s Disease
  • 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
  • Medically stable and capable of receiving radiation therapy as assessed by the treating radiation oncologist
  • Reliable caregiver or informant able to accompany the patient to ≥80% of scheduled visits
  • Written informed consent from patient (if decision-making capacity is preserved) and/or legally authorized representative (LAR); caregiver co-consent required
  • Life expectancy ≥18 months in the opinion of the treating physician
  • Ability and willingness to comply with monthly clinic visits for the 12-month maintenance period
  • \--------------------------------------------------------------------------------------

Exclusion 15

  • 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.
  • 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
  • Active autoimmune encephalitis in acute phase (patients in stable chronic phase are eligible)
  • Uncontrolled systemic infection or active sepsis at enrollment
  • Severe psychiatric comorbidity (active psychosis, active suicidal ideation) impairing protocol compliance or safety assessment
  • Concurrent enrollment in another interventional trial targeting cognitive decline or neuroinflammation
  • Pregnancy or lactation; women of childbearing potential must use adequate contraception
  • Inability to lie flat and still for radiation delivery (approximately 10-15 minutes per session)
  • MoCA \<10 at baseline screening (severe dementia; insufficient cognitive range for endpoint assessment)

Where

1 site, 1 recruiting

Renaissance Institute of Precision Oncology & Radiosurgery

Winter Park, Florida, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.