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New treatment option for Alzheimer Dementia
Official title Low-Dose Radiotherapy for Alzheimer's Disease
ClinicalTrials.gov ID: NCT07693140
What this study is testing
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- Known active cerebral amyloid angiopathy-related inflammation (CAA-ri) or amyloid-related beta-angiitis (ABRA), whether confirmed by biopsy, CSF...
- Active autoimmune encephalitis in acute phase (patients in stable chronic phase are eligible)
See the full eligibility criteria
- 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...
- 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 \--------------------------------------------------------------------------------------
- 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...
- 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...
- 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 treatment 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)
The study team makes the final eligibility decision.
Where it's taking place
- Winter Park, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winter Park, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.