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Hormone Therapy

Allo APOE4 carriers for Parkinson's Disease (Allo-PD Trial)

Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly from week 1 to week 16
Awards & highlights

Allo-PD Trial 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.Check my eligibility
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.See study design
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.

Allo-PD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Parkinson's disease without a known cause.
Select...
My Parkinson's disease is between stages 1 to 4.

Allo-PD Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Study completion
Secondary outcome measures
Adverse Events
Infusion Reactions
Pharmacokinetics: Area under the plasma concentration versus time curve (AUC)
+3 more
Other outcome measures
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

Allo-PD 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

Find a Location

Who is running the clinical trial?

Roberta BrintonLead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Roberta D Brinton, PhDStudy ChairUniversity of Arizona
3 Previous Clinical Trials
312 Total Patients Enrolled
Gerson D Hernandez, MD, MPHStudy DirectorUniversity of Arizona
3 Previous Clinical Trials
432 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available vacancies for potential participants in this research study?

"Yes, the details on clinicaltrials.gov show that this investigation is actively seeking participants. It was initially shared on January 12th, 2024, and the latest update occurred on February 8th, 2024. The study aims to recruit ten individuals from a single site."

Answered by AI

What is the safety profile of Allo for individuals who are carriers of the APOE4 gene variant?

"The safety rating for Allo APOE4 carriers based on our team's evaluation at Power is 1, reflecting the early Phase 1 nature of this trial with limited evidence supporting its safety and efficacy."

Answered by AI

How large is the participant pool for this particular medical study?

"Affirmative. Information provided by clinicaltrials.gov indicates that this research trial is presently in need of participants. The study was first posted on January 12th, 2024 and last updated on February 8th, 2024. A total of 10 individuals are being sought from a single site."

Answered by AI

Is there an age cutoff of 70 years for participants in this research study?

"Individuals aged above 40 and below 85 are eligible for recruitment into this clinical trial."

Answered by AI

Who else is applying?

What site did they apply to?
The University of Arizona Clinical & Translational Science Research Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Allopregnanolone as a Regenerative Treatment for Parkinson's Disease
Roberta Brinton 2024. "Allopregnanolone as a Regenerative Treatment for Parkinson's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06263010.
All > Tucson
~6 spots leftby Sep 2024
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