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Neurosteroid
Allopregnanolone for Alzheimer's Disease (REGEN-BRAIN© Trial)
Phase 2
Recruiting
Led By Roberta D Brinton, PhD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and postmenopausal women
APOE ε4 positive
Must not have
History of stroke with a modified Hachinski Ischemic Scale score >4
Unstable or clinically significant cardiovascular, kidney or liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 and 18 months
Awards & highlights
Summary
This trial will test if a drug can safely and effectively treat Alzheimer's disease.
Who is the study for?
This trial is for men and postmenopausal women aged 55-80 with mild Alzheimer's, as indicated by certain criteria and test scores. Participants must not have had a stroke or other forms of dementia, be free from serious heart, kidney or liver issues, and cannot take specific medications that affect the brain's GABA receptors.
What is being tested?
The study tests Allopregnanolone against a placebo to see if it can help regenerate brain function in Alzheimer's patients. It's a phase 2 trial where participants are randomly assigned to receive either the drug or an inactive substance without knowing which one they're getting.
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include reactions at the injection site, changes in mood or behavior due to its action on GABA receptors in the brain, and possible interactions with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man or a woman who has gone through menopause.
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I have the APOE ε4 gene.
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I understand and can agree to the study's procedures and risks.
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I am between 55 and 80 years old.
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My memory and thinking skills are mildly impaired.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had a stroke and my condition is considered moderate to severe.
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I do not have serious heart, kidney, or liver problems.
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I have had cancer or a recurrence of cancer in the last 5 years.
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My MRI shows significant brain abnormalities.
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I have a history of seizures, brain injuries, or brain lesions.
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I have no health issues that prevent me from having an MRI.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 12 and 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 and 18 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Hippocampal volume
Secondary study objectives
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 11
Alzheimer's Disease
Cambridge Cognition's Paired Associates Learning Test
+2 moreOther study objectives
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 14
Arterial spin labeling (ASL)
Clinical Dementia Rating (CDR)
+9 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Allo groupExperimental Treatment1 Intervention
Allopregnanolone 4mg IV 30-minute infusion once per week for 12 months.
Group II: Control groupPlacebo Group1 Intervention
Placebo (normal saline) IV 30-minute infusion once per week for 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Allopregnanolone
2019
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaOTHER
936 Previous Clinical Trials
1,613,281 Total Patients Enrolled
University of ArizonaLead Sponsor
525 Previous Clinical Trials
155,048 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,733 Previous Clinical Trials
28,054,803 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a man or a woman who has gone through menopause.I have had a stroke and my condition is considered moderate to severe.I have the APOE ε4 gene.I do not have serious heart, kidney, or liver problems.I have had cancer or a recurrence of cancer in the last 5 years.I understand and can agree to the study's procedures and risks.I am between 55 and 80 years old.My MRI shows significant brain abnormalities.Your score on the Geriatric Depression Scale short form (GDS-S) is less than or equal to 6.You have symptoms of Alzheimer's disease that meet specific criteria.I have a history of seizures, brain injuries, or brain lesions.I am not taking medications that affect the GABA-A receptor.You have a type of dementia other than probable Alzheimer's disease.My memory and thinking skills are mildly impaired.I have no health issues that prevent me from having an MRI.
Research Study Groups:
This trial has the following groups:- Group 1: Allo group
- Group 2: Control group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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