RecruitingPhase 1 / Phase 2

Low-Dose Radiotherapy for Alzheimer's Disease

Low-Dose Radiotherapy for Alzheimer's Disease: A Phase I/II Open-Label Feasibility and Safety Study (LDRT-MIND Trial)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe low-dose radiation to the whole brain is and how well people can handle it. It is for adults age 50 or older with Alzheimer's disease or certain other types of dementia with inflammation. Treatment starts with a first course, followed by monthly treatment over 12 months.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 50 or older, with a doctor expecting you to live at least 18 months.
  • Have a specialist-confirmed diagnosis of Alzheimer's disease, frontotemporal dementia with inflammation, Lewy body dementia with signs of inflammation in spinal fluid, or another dementia with confirmed brain inflammation.
  • Score 10–25 on the MoCA, a test of memory and thinking.
  • Meet the required score on a daily activity scale: KPS of at least 60 or ECOG of 2 or less.
  • Be medically stable and able to receive radiation, as judged by the radiation doctor.
  • Have a reliable caregiver or other person who knows you well attend at least 80% of visits.
  • Give written consent yourself if able, and/or through a legally authorized person. A caregiver must also give consent.
  • Be able and willing to attend monthly clinic visits during the 12-month treatment period.

Who can't join

  • Have ever had radiation to any part of the brain, or have an implanted device that is not safe with radiation.
  • Have active cancer needing treatment during the study, an uncontrolled infection, or active sepsis—a serious response to infection.
  • Have an MRI showing more than 4 tiny brain bleeds, more than 1 area of old blood deposits on the brain surface, severe damage to the brain's white matter (Fazekas grade 3), any large brain bleed, or an old-blood-stained area larger than 10 mm.
  • Have active inflammation linked to amyloid protein in brain blood vessels (CAA-ri or ABRA), or a sudden active phase of immune-system-related brain inflammation. A stable, long-term phase of the latter is allowed.
  • Have severe mental health symptoms, such as losing touch with reality or current thoughts of suicide, that affect safe participation or study checks.
  • Be in another treatment study aimed at memory and thinking loss or brain inflammation.
  • Be pregnant or breastfeeding. Women who can become pregnant must use adequate birth control.
  • Be unable to lie flat and still for about 10–15 minutes per radiation session, or score below 10 on the MoCA memory and thinking test.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

FL