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Methylene Blue

Phenazopyridine hydrochloride for Mild Cognitive Impairment (MB2 Trial)

Phase 2

Waitlist Available

Research Sponsored by The University of Texas Health Science Center at San Antonio

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 baseline, change from baseline at 2 weeks ± 3 days, change from baseline at 12 weeks ± 3 days

Awards & highlights

MB2 Trial Summary

This trial is investigating whether methylene blue can improve cognitive abilities in people with mild Alzheimer's disease.

Eligible Conditions

Mild Cognitive Impairment
Alzheimer's Disease
Aging

MB2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, change from baseline at 2 weeks ± 3 days, change from baseline at 12 weeks ± 3 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, change from baseline at 2 weeks ± 3 days, change from baseline at 12 weeks ± 3 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, change from baseline at 2 weeks ± 3 days, change from baseline at 12 weeks ± 3 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Episodic memory task

Episodic memory task response

Neuropsychological battery composite score

+4 more

Secondary outcome measures

Cerebral blood flow measures

Other outcome measures

CO2 challenge

Functional Connectivity measures

MB2 Trial Design

8Treatment groups

Experimental Treatment

Placebo Group

Group I: Mild Cognitive Impairment (MCI) MBExperimental Treatment2 Interventions

Methylene Blue (USP grade, 282 mg oral, daily, 2 weeks, 12 weeks) Phenazopyridine hydrochloride (97.5 mg oral, 2 weeks, 12 weeks)

Group II: Mild Alzheimer's Disease (AD) MBExperimental Treatment2 Interventions

Methylene Blue (USP grade, 282 mg oral, daily, 2 weeks, 12 weeks) Phenazopyridine hydrochloride (97.5 mg oral, 2 weeks, 12 weeks)

Group III: Healthy Middle Age MBExperimental Treatment2 Interventions

Methylene Blue (USP grade, 282 mg oral, daily, 2 weeks, 12 weeks) Phenazopyridine hydrochloride (97.5 mg oral, 2 weeks, 12 weeks)

Group IV: Healthy Aging MBExperimental Treatment2 Interventions

Methylene Blue (USP grade, 282mg oral, daily, 2 weeks, 12 weeks) Phenazopyridine hydrochloride (97.5 mg oral, 2 weeks, 12 weeks)

Group V: Healthy Middle Age PlaceboPlacebo Group2 Interventions

Drug: FD&C Blue # 2 (USP grade, 282 mg oral, 2 weeks, 12 weeks) Phenazopyridine hydrochloride (97.5 mg oral, 2 weeks, 12 weeks)

Group VI: Healthy Aging PlaceboPlacebo Group2 Interventions

Drug: FD&C Blue # 2 (USP grade, 282 mg oral, 2 weeks, 12 weeks) Phenazopyridine hydrochloride (97.5 mg oral, 2 weeks, 12 weeks)

Group VII: Mild Cognitive Impairment (MCI) PlaceboPlacebo Group2 Interventions

Drug: FD&C Blue # 2 (USP grade, 282 mg oral, 2 weeks, 12 weeks) Phenazopyridine hydrochloride (97.5 mg oral, 2 weeks, 12 weeks)

Group VIII: Mild Alzheimer's Disease (AD) PlaceboPlacebo Group2 Interventions

Drug: FD&C Blue # 2 (USP grade, 282 mg oral, 2 weeks, 12 weeks) Phenazopyridine hydrochloride (97.5 mg oral, 2 weeks, 12 weeks)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylene Blue

2021

Completed Phase 4

~1390

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

452 Previous Clinical Trials

91,297 Total Patients Enrolled

Texas Alzheimer's Research and Care Consortium (TARCC)UNKNOWN

Frequently Asked Questions

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

Is Phenazopyridine hydrochloride likely to be harmful if ingested?

"According to the team at Power, Phenazopyridine hydrochloride was rated a 2 on their safety scale. This is because Phase 2 trials have demonstrated some evidence of its security profile but none for efficacy."

Answered by AI

How many eligible participants are participating in this trial?

"This investigation is not accepting applications at this moment. The research study was first listed on July 1st, 2015 and most recently updated August 25th, 2022. If you're looking for other trials, there are 1193 clinical studies recruiting patients with mci and 11 open studies searching for participants to take Phenazopyridine hydrochloride."

Answered by AI

Is this clinical study open to participants who are of legal age?

"This clinical trial only allows patients between the ages of 45 and 89 to enroll. Conversely, there are a total of 1151 trials specifically designed for those over 65 years in age, as well as 45 studies targeting individuals under 18."

Answered by AI

In what ways is Phenazopyridine hydrochloride used in medical treatment?

"Phenazopyridine hydrochloride is generally used to ameliorate trauma. However, it also has potential in treating afflictions such as nephritis, discomfort and urinary tract infections."

Answered by AI

Is this particular research endeavor a pioneering effort?

"At present, 11 clinical studies of Phenazopyridine hydrochloride are in progress across 8 cities and 5 countries. This drug's first trial occurred nearly 13 years ago in 2008; Universal Enterprises was the sponsor, 24 patients were involved and it successfully completed its N/A drug approval stage. Since then, 45 trials have been conducted to full completion."

Answered by AI

May I participate in this clinical research?

"For acceptance into this medical research, the minimum requirements are mild cognitive impairment and a patient's age must be between 45 to 89 years old. The investigators aim to recruit 117 participants in total."

Answered by AI

Is recruitment still open for this experiment?

"Unfortunately, this medical research is no longer taking enrollees. The listing was initially posted on July 1st 2015 and most recently updated August 25th 2022. If you are in search of other trials, 1193 studies with MCI criteria are recruiting patients while 11 clinical trials for Phenazopyridine hydrochloride still have open positions available."

Answered by AI