Alzheimer's Disease Research Study
Leading U.S. Researchers are conducting a clinical study in the U.S. for people with mild stage Alzheimer’s disease to regenerate and restore the brain. Participants will receive once-weekly infusions of either allopregnanolone or a placebo for six months. Then, all participants will go on to receive allopregnanolone for three months.
Fast Facts
Diagnosed With Mild Stage Alzheimer's Disease
55-80
Years Old
No History of Seizure Disorder, Brain Lesion, or Traumatic Brain Injury
Compensation
Provided
Study Background
The ReGenBRAIN study is evaluating whether an investigational drug, allopregnanolone (ALLO), may support brain health in individuals with mild Alzheimer’s disease.
ReGenBRAIN is a Phase 2 clinical trial designed to explore the effects of allopregnanolone (ALLO), a naturally occurring molecule in the human body, on brain structure and function in participants with mild Alzheimer’s disease. Although ALLO has been studied for other conditions, it has not been approved by the FDA for Alzheimer’s disease and is considered experimental for this use.
In this study, researchers are testing how ALLO may affect brain regeneration by comparing it to a placebo over a six-month period. Afterward, all participants—including those who initially received placebo—will receive ALLO for three months. Weekly clinic visits, imaging, lab tests, and assessments will track changes in brain function and overall safety. A total of 100 participants will be enrolled.
Study Background
The ReGenBRAIN study is evaluating whether an investigational drug, allopregnanolone (ALLO), may support brain health in individuals with mild Alzheimer’s disease.
ReGenBRAIN is a Phase 2 clinical trial designed to explore the effects of allopregnanolone (ALLO), a naturally occurring molecule in the human body, on brain structure and function in participants with mild Alzheimer’s disease. Although ALLO has been studied for other conditions, it has not been approved by the FDA for Alzheimer’s disease and is considered experimental for this use.
In this study, researchers are testing how ALLO may affect brain regeneration by comparing it to a placebo over a six-month period. Afterward, all participants—including those who initially received placebo—will receive ALLO for three months. Weekly clinic visits, imaging, lab tests, and assessments will track changes in brain function and overall safety. A total of 100 participants will be enrolled.
Participating Research Sites
Participating Institutions:
Perseverance Research Center LLC PRC – Scottsdale, Arizona
ATP Clinical Research, Inc – Costa Mesa, California
Syrentis Clinical Research – Santa Ana, California
MedVadis Research Corp – Waltham, Massachusetts
Optimus U Corp – Miami, Florida
Miami Jewish Health – Miami, Florida
Combined Research Orlando – Orlando, Florida
Conquest Research – Winter Park, Florida
University of Arizona – Tucson, Arizona
Additional Information
The ReGenBRAIN study is being conducted to explore whether the investigational drug allopregnanolone can regenerate the brain and support brain health and function in individuals with mild Alzheimer’s disease.
You may be eligible for this study if you meet the following criteria.
Inclusion Criteria:
- Diagnosed with mild stage Alzheimer’s disease
- No history of seizure disorder, brain lesion, or traumatic brain injury
- Ages 55-80
- No dementia other than probable Alzheimer’s disease
- Able to undergo MRI scan (no metal in the body, no claustrophobia)
- Men and postmenopausal women
If you qualify and decide to join:
You will first complete a screening process, including medical evaluations and imaging.
If eligible, you will be randomly assigned to receive either the study drug or placebo for six months (once-weekly infusions).
After six months, all participants—including those who previously received placebo—will receive the study drug for three months.
You and your caregiver/study partner will attend weekly in-person visits with your study doctor, which may include physical exams, MRIs, lab tests, and questionnaires.
Yes, participants will receive compensation for each completed study visit. Compensation starts at $50.00 for participants and $40.00 for caregivers per visit.
There is no cost for you to participate in our research study.