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Alpha-1 Adrenergic Blocker
Prazosin for Dementia (PoND Trial)
Phase 4
Waitlist Available
Led By Murray A. Raskind, MD
Research Sponsored by VA Office of Research and Development
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 10 weeks
Awards & highlights
PoND Trial Summary
This trial is testing whether prazosin can help remove tau and beta amyloid from the brain, which are linked to chronic traumatic encephalopathy (CTE) and Alzheimer's disease (AD).
PoND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Amyloid Beta 42 From Baseline to End of Study (pg/mL)
Change in CSF Total-tau From Baseline to End of Study (pg/mL)
Change in p-tau181 From Baseline to End of Study (pg/mL)
PoND Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PrazosinExperimental Treatment1 Intervention
Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will be titrated up to the maximum dose or the maximum tolerated dose based on a dosing algorithm. The maximum dose is 5 mg in the morning, 5 mg in the afternoon and 15 mg at bedtime.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
prazosin hydrochloride
2001
Completed Phase 2
~550
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,594 Total Patients Enrolled
23 Trials studying Dementia
4,229 Patients Enrolled for Dementia
Murray A. Raskind, MDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
3 Previous Clinical Trials
394 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have experienced a serious head injury with a long period of unconsciousness or memory loss.You are currently taking prazosin or trazodone, or you have taken them in the past 3 months, because they might affect the measurements needed for the study.You have a serious or unstable medical condition such as recent heart problems, low blood pressure, or autoimmune disorders.You have been diagnosed with PTSD related to combat trauma from any war.Your platelet count is higher than 100,000 per cubic millimeter within two weeks before a lumbar puncture.Your body mass index (BMI) should be between 18 and 36. If it's not, it can affect the measurements of certain substances in your body and make specific medical procedures harder to do.You have long-term kidney or liver problems, have had pancreatitis recently, or have certain specific medical conditions related to dizziness and sleep.You cannot have a lumbar puncture if you have spinal cord injury, severe disease or infection in the lower back, bleeding or clotting issues, or have had trauma or infection in the past 4 weeks.You have a current addiction to drugs (except for caffeine, tobacco, or cannabis not causing addiction), unless in remission for at least 3 months.You have taken certain medications for conditions like mental health, blood clotting, inflammation, and HIV in the past 4 weeks.You have had trauma- or sleep-focused therapy like Prolonged Exposure therapy, Cognitive Processing Therapy, Eye Movement Desensitization and Reprogramming, Cognitive Behavioral Therapy for Insomnia, or Image Rehearsal and Rescripting therapy for nightmares within the past 4 weeks.Your lab test results must be normal for you to participate.You need to meet the requirements for at least one of the following.You have had an allergic reaction to prazosin or similar medications in the past.You are currently taking medications or supplements that have stimulant or vasodilatory effects.You are currently taking any stimulant medications, even if they are prescribed by a doctor.You have had a head injury from a blast or collision with symptoms like loss of consciousness or memory loss that meet specific criteria, and this injury occurred within the last 6 months.You have been diagnosed with schizophrenia, schizoaffective disorder, or other serious mental health conditions as per the doctor's evaluation.You have severe mental health issues or are in a crisis situation, including being actively suicidal or homicidal, or behaving in a way that could harm you or others.You cannot use certain medications for erectile dysfunction during the initial dose adjustment period. After the adjustment period, you can use these medications at half the usual starting dose.Your body mass index (BMI) should be between 18 and 36. This is because having a BMI outside of this range can affect the accuracy of certain measurements and make it hard to collect fluid from your spine.You have had a head injury or concussion with certain symptoms that meet specific criteria, or you have been diagnosed with PTSD related to combat trauma.
Research Study Groups:
This trial has the following groups:- Group 1: Prazosin
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What has been discovered about the security of prazosin hydrochloride for individuals?
"Due to the Phase 4 classification of prazosin hydrochloride, which implies approval, our team at Power concluded that it is safe enough to assign a score of 3."
Answered by AI
What conditions can be alleviated by the use of prazosin hydrochloride?
"Prazosin hydrochloride has multiple applications, including treating PTSD, alleviating hypertension-related issues, and managing nightmares or BPH."
Answered by AI
What prior research has been conducted on the effectiveness of prazosin hydrochloride?
"At present, there are 7 ongoing trials for prazosin hydrochloride with 1 trial in the final Phase 3 stage. Seattle is one of 9 locations hosting studies on this drug and has multiple clinical sites available."
Answered by AI
How many individuals are enrolled in this clinical trial at present?
"Currently, this trial is not taking on new patients. The clinical trial was posted in December 2016 and last updated January 2021. For those looking to join similar studies, there are 394 dementia trials that remain open for enrollment as well as 7 prazosin hydrochloride research initiatives actively seeking participants."
Answered by AI
Is there any room for new participants in this clinical experiment?
"As indicated on clinicaltrials.gov, this study is not admitting applicants at the moment. The original posting was published December 1st 2016 with its last update occurring January 7th 2022. At present, there are 401 other medical trials actively looking for participants to join their research endeavors."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What site did they apply to?
VA Puget Sound Health Care System Seattle Division, Seattle, WA
What portion of applicants met pre-screening criteria?
Did not meet criteria
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