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Neurosteroid

Allopregnanolone for Alzheimer's Disease (REGEN-BRAIN© Trial)

Phase 2

Recruiting

Led By Lon Schneider, MD

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 and 18 months

Awards & highlights

REGEN-BRAIN© Trial 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.Check my eligibility

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.See study design

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.

REGEN-BRAIN© Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

REGEN-BRAIN© Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hippocampal volume

Secondary outcome measures

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 11

Alzheimer's Disease

Cambridge Cognition's Paired Associates Learning Test

+2 more

Other outcome measures

Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) 14

Arterial spin labeling (ASL)

Clinical Dementia Rating (CDR)

+9 more

REGEN-BRAIN© Trial 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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaOTHER

906 Previous Clinical Trials

1,596,088 Total Patients Enrolled

University of ArizonaLead Sponsor

514 Previous Clinical Trials

148,394 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,675 Previous Clinical Trials

28,020,685 Total Patients Enrolled

Media Library

Allopregnanolone (Neurosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04838301 — Phase 2

Neurodegenerative Disease Research Study Groups: Allo group, Control group

Neurodegenerative Disease Clinical Trial 2023: Allopregnanolone Highlights & Side Effects. Trial Name: NCT04838301 — Phase 2

Allopregnanolone (Neurosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04838301 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria allow for participants older than 20 years?

"This trial has established an age range of 55 to 80 years old for patient inclusion."

Answered by AI

Does Allo group adhere to the FDA's regulatory standards?

"Allo group's safety rating is a 2, as there exists some evidence of its security but not yet any data to back up efficacy claims."

Answered by AI

Are there any openings left for those wishing to partake in the research?

"Indeed, the records on clinicaltrials.gov point to this medical trial actively recruiting patients. Initiated on August 15th 2023, it is currently looking for 200 individuals across one location."

Answered by AI

How many participants are eligible to partake in this research endeavor?

"Affirmative. The clinicaltrials.gov database implies that this experiment, which was initially made available on August 15th 2023, is still recruiting participants. Approximately 200 volunteers need to be acquired from a single medical facility."

Answered by AI

Has the Allo group taken part in other investigations of this kind?

"Presently, there are three ongoing experiments evaluating Allo group with none in the Phase 3 stage. Most of these studies can be found in Miami, FL though another four sites across the country feature research into this topic."

Answered by AI

May I be included as a subject for this clinical trial?

"This medical trial is seeking to enrol 200 individuals aged 55-80 who are suffering from a neurodegenerative disorder. Eligibility requirements include being an adult male or postmenopausal female, meeting the NIA-AA criteria for probable Alzheimer's disease dementia diagnosis, having an MMSE score of 20-26 and APOE ε4 positive status, Geriatric Depression Scale short form (GDS-S) ≤ 6 score, no medical issues that could create safety hazards during participation in this study, and capacity to provide informed consent at screening."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease

Roberta Brinton 2023. "Allopregnanolone Regenerative Therapeutic for Mild Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04838301.

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