Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Low Dose Radiation Therapy · 1 trial · 5 indications
The primary endpoint is the proportion of participants who experience at least one treatment-related adverse event of Grade 3 or higher, graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Adverse events are assessed continuously and attributed to study treatment (induction plus monthly maintenance low-dose whole-brain radiotherapy) by the investigator. Feasibility is defined by an acceptable rate of Grade 3 or higher treatment-related events: 15% or lower during the Phase I lead-in (first 10 participants) and 20% or lower across the full study population (N=50). Safety is monitored continuously using a Bayesian Beta-Binomial model; the study pauses for Data Safety Monitoring Board review if the posterior probability that the true Grade 3 or higher rate exceeds 20% reaches 0.80 or greater.
| Arm | Type | Description |
|---|---|---|
| Treatment Group | EXPERIMENTAL | Low dose radiotherapy in 10 induction treatments followed by 10 maintenance treatments spread across each month starting at 2 month post- induction |
| Name | Type | Description |
|---|---|---|
| Low Dose Radiation Therapy | RADIATION | Low dose whole brain radiotherapy delivered as an induction course of 10 fractions followed by 12 months of monthly maintenance LDRT in 10 fractions starting 2 months post-induction |
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....
Low Dose Radiation Therapy is an investigational treatment being studied for Alzheimer Dementia. It is currently in Phase 1 clinical development. The therapy is being evaluated in a clinical trial enrolling 50 participants with Alzheimer's disease and related dementias in the United States.
Low Dose Radiation Therapy is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DTIL. The company is conducting a Phase 1 clinical trial of this therapy for Alzheimer Dementia.
Low Dose Radiation Therapy is in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. The ongoing Phase 1 trial is currently recruiting participants in the United States.
Low Dose Radiation Therapy is being studied in a single Phase 1 clinical trial with the identifier NCT07693140, titled "Low-Dose Radiotherapy for Alzheimer's Disease." The trial is recruiting 50 participants aged 50 years and older with Alzheimer Dementia in the United States.
No, the Phase 1 clinical trial of Low Dose Radiation Therapy for Alzheimer Dementia is not randomized and does not use a control group. It is an uncontrolled, open-label study. The trial is not double-blind and does not involve a placebo or active comparator.