NCT07693140 Low-Dose Radiotherapy for Alzheimer's Disease
| NCT ID | NCT07693140 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Evan Thomas |
| Condition | Alzheimer Dementia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-07-15 |
| Primary Completion | 2029-05-21 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2026-07-15 with a primary completion date of 2029-05-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 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 9. Ability and willingness to comply with monthly clinic visits for the 12-month maintenance period \-------------------------------------------------------------------------------------- Exclusion Criteria: 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 9. Concurrent enrollment in another interventional trial targeting cognitive decline or neuroinflammation 10. Pregnancy or lactation; women of childbearing potential must use adequate contraception 11. Inability to lie flat and still for radiation delivery (approximately 10-15 minutes per session) 12. MoCA \<10 at baseline screening (severe dementia; insufficient cognitive range for endpoint assessment)
Contact & Investigator
Evan Thomas, MD, PhD
PRINCIPAL INVESTIGATOR
Renaissance Institute of Precision Oncology and Radiosurgery
Frequently Asked Questions
Who can join the NCT07693140 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Alzheimer Dementia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07693140 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07693140 currently recruiting?
Yes, NCT07693140 is actively recruiting participants. Contact the research team at jpierson@therenaissanceinstitute.org for enrollment information.
Where is the NCT07693140 trial being conducted?
This trial is being conducted at Winter Park, United States.
Who is sponsoring the NCT07693140 clinical trial?
NCT07693140 is sponsored by Evan Thomas. The principal investigator is Evan Thomas, MD, PhD at Renaissance Institute of Precision Oncology and Radiosurgery. The trial plans to enroll 50 participants.
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