← Back to Search

Neurosteroid

Allopregnanolone for Alzheimer's Dementia (Allo-IM Trial)

Phase 1

Waitlist Available

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visits 8-9 and 11-15 (up to 8 weeks)

Awards & highlights

Allo-IM Trial Summary

This trial is testing a new way to give a weekly dose of a medication that is typically given intravenously.

Eligible Conditions

Alzheimer's Dementia

Allo-IM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visits 8-9 and 11-15 (up to 8 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visits 8-9 and 11-15 (up to 8 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visits 8-9 and 11-15 (up to 8 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Safety - Adverse events

Safety - clinical assessment

Safety - clinical laboratory measures

Secondary outcome measures

Pharmacokinetic parameter - AUC

Pharmacokinetic parameter - Clearance

Pharmacokinetic parameter - Cmax

+3 more

Other outcome measures

Actigraphy sleep assessment - Sleep efficiency

Actigraphy sleep assessment - Total sleep time

Actigraphy sleep assessment - Wake after sleep onset

+9 more

Allo-IM Trial Design

1Treatment groups

Experimental Treatment

Group I: Allo IM cohortExperimental Treatment1 Intervention

Allopregnanolone 4-18mg IM, weekly, for 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allopregnanolone

2019

Completed Phase 2

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor

514 Previous Clinical Trials

148,261 Total Patients Enrolled

University of Southern CaliforniaOTHER

905 Previous Clinical Trials

1,596,266 Total Patients Enrolled

Alzheimer's AssociationOTHER

89 Previous Clinical Trials

40,751 Total Patients Enrolled

Frequently Asked Questions

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

How many participants are anticipated for this clinical experiment?

"Unfortunately, this particular research no longer requires participants. The trial was launched on October 1st 2019 and last modified on May 23rd 2022. If you are looking for alternative studies, there is currently 762 trials recruiting patients with dementia as well as 5 investigations into Allopregnanolone that require volunteers."

Answered by AI

Are there any potential hazards to using Allopregnanolone?

"Our team at Power believes the safety of Allopregnanolone to be a 1, due to its status as a Phase 1 trial. This indicates there is minimal clinical data available on both efficacy and risk factors."

Answered by AI

What are the desired end-results of this medical experimentation?

"This trial will run for 14 weeks and measure the safety of a drug through clinical assessment. Additionally, pharmacokinetic parameters such as AUC (area under the curve), Cmax (maximum serum concentration) and Tmax (time at which Cmax is attained) must also be evaluated."

Answered by AI

Could you please outline other research initiatives that have been done on Allopregnanolone?

"Currently, there are 5 active clinical trials exploring the efficacy of Allopregnanolone with none in Phase 3. These studies are primarily located in Durham, North carolina but can also be found at other locations across the USA."

Answered by AI

Are researchers currently accepting new participants for this study?

"As per clinicaltrials.gov, this medical experiment is no longer recruiting patients since the last update on May 23rd 2022. Despite that fact, there are 767 other studies currently enrolling volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: Intramuscular Study

Roberta Brinton 2019. "Allopregnanolone Regenerative Therapeutic for Early Alzheimer's Disease: Intramuscular Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03748303.