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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,2 weeks ± 3 days,12 weeks ± 3 days

Summary

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

Eligible Conditions
  • Alzheimer's disease
  • Mild Cognitive Impairment
  • Alzheimer's Disease
  • Aging

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline,2 weeks ± 3 days,12 weeks ± 3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline,2 weeks ± 3 days,12 weeks ± 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
CLOX: An Executive Clock Drawing Test
FNAME
Mini-Mental State Exam (MMSE)
+6 more
Secondary study objectives
Cerebral Blood Flow Measures
Other study objectives
CO2 Challenge
Functional Connectivity Measures

Side effects data

From 2023 Phase 2 trial • 117 Patients • NCT02380573
100%
blue or orange urine
55%
urinary frequency or urgency
55%
green stool
32%
bladder irritation
27%
vomiting or nausea
18%
leg cramps
9%
diarrhea/loose stool
5%
fever
5%
decreased libido
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mild Alzheimer's Disease (AD) Placebo
Healthy Aging MB
Healthy Aging Placebo
Mild Alzheimer's Disease (AD) MB
Mild Cognitive Impairment (MCI) MB
Mild Cognitive Impairment (MCI) Placebo

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
~1530
Phenazopyridine hydrochloride
2015
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
475 Previous Clinical Trials
92,199 Total Patients Enrolled
Texas Alzheimer's Research and Care Consortium (TARCC)UNKNOWN
~11 spots leftby Nov 2025
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