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Hormone Therapy

Allopregnanolone for Parkinson's Disease (Allo-PD Trial)

Phase 1

Waitlist Available

Led By Scott Sherman, MD

Research Sponsored by Roberta Brinton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of Idiopathic sporadic Parkinson disease

Hoehn & Yahr stage 1-4

Must not have

Undergone deep brain stimulation (DBS) surgery as treatment for PD

Evidence of Parkinsonian syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weekly from week 1 to week 16

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a potential treatment called allopregnanolone in patients with Parkinson's disease. The study aims to determine if a larger clinical trial is possible, assess the safety and tolerability

Who is the study for?

This trial is for individuals with Parkinson's Disease. Participants will receive weekly infusions of allopregnanolone over 12 weeks. There are specific inclusion and exclusion criteria, but they're not listed here.

What is being tested?

The study tests allopregnanolone as a potential regenerative treatment for Parkinson's Disease. It aims to determine the feasibility of a larger trial, assess safety and tolerability, and look for any positive changes in brain imaging and clinical assessments.

What are the potential side effects?

Since this summary doesn't provide details on side effects, it can be assumed that part of the study's purpose is to identify them. Typically, participants are monitored closely for any adverse reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Parkinson's disease without a known cause.

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My Parkinson's disease is between stages 1 to 4.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had DBS surgery for Parkinson's disease.

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I have been diagnosed with Parkinson's disease.

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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 ~ weekly from week 1 to week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weekly from week 1 to week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly from week 1 to week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Study completion

Secondary study objectives

Adverse Events

Infusion Reactions

Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)

+3 more

Other study objectives

Cambridge Cognition's Motor Screening Task (MOT)

Cambridge Cognition's One Touch Stockings of Cambridge (OTS)

Cambridge Cognition's Paired Associates Learning (PAL) Test

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Allo APOE4 carriersExperimental Treatment1 Intervention

Group of 5 participants who are carriers of the APOE4 gene and will receive allopregnanolone 4mg administered weekly via a 30-min IV infusion for a duration of 12 weeks.

Group II: Allo APOE4 none-carriersActive Control1 Intervention

Group of 5 participants who are none-carriers of the APOE4 gene and will receive allopregnanolone 4mg administered weekly via a 30-min IV infusion for a duration of 12 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allopregnanolone

2019

Completed Phase 2

~30

0 / 5Eligibility criteria met