Cognitive and Functional Connectivity Effects of Methylene Blue in Healthy Aging, Mild Cognitive Impairment and Alzheimer's Disease

Status: Completed

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 2

SUMMARY

A double-blind, placebo-controlled study that aims to investigate the effect of 2-week and 12-week administration of USP methylene blue (MB) on cerebral blood flow, functional connectivity, memory and attention cognitive abilities using fMRI and behavioral measures in healthy aging, mild cognitive impairment (MCI) and mild Alzheimer's disease (AD) subjects.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 45

Maximum Age: 89

Healthy Volunteers: t

View:

• 45-89 years old

• All genders

• All minorities

• English, Spanish, or multilingual speakers

• Postmenopausal or surgically sterile females only.

• Inclusion for MCI group only: participants will meet the criteria for amnestic and non-amnestic MCI such as those currently used by Texas Alzheimer's Research and Care Consortium (TARCC) consensus diagnosis

• Inclusion for AD group only: Alzheimer's Early-stage, sporadic-type

Locations

United States

Texas

Research Imaging Institute, The University of Texas Health Science Center at San Antonio

San Antonio

Time Frame

Start Date: 2015-07

Completion Date: 2023-07

Participants

Target number of participants: 117

Treatments

Experimental: Healthy Aging MB

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

Placebo_comparator: Healthy Aging Placebo

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

Experimental: Mild Cognitive Impairment (MCI) MB

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

Placebo_comparator: Mild Cognitive Impairment (MCI) Placebo

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

Experimental: Mild Alzheimer's Disease (AD) MB

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

Placebo_comparator: Mild Alzheimer's Disease (AD) Placebo

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

Experimental: Healthy Middle Age MB

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

Placebo_comparator: Healthy Middle Age Placebo

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

Authors

Timothy Q. Duong, Peter T. Fox, Pavel Rodriguez

Related Therapeutic Areas

Alzheimer's Disease

Dementia

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Cognitive and Functional Connectivity Effects of Methylene Blue in Healthy Aging, Mild Cognitive Impairment and Alzheimer's Disease

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