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

What Was Tested

This registered phase 2 trial tested Methylene blue (non-peptide stack partner).

It had eight arms (groups): one (experimental), one (placebo comparator), Mild Cognitive Impairment (MCI) MB (experimental), Mild Cognitive Impairment (MCI) Placebo (placebo comparator) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

After informed consent and familiarity with the tasks and the MRI environment, the subject will enter an MRI scanner and perform the following 6 tasks. fMRI and behavioral data will be collected simultaneously while inside the scanner.

Delayed match-to-sample task: The subject views a pattern for a few seconds and then is prompted to recall the memorized pattern using a response system (approx. 10 mins).

In a later run, the subjects are asked whether the correct name is matched with the correct face.

Psychomotor vigilance task: The subject receives a visual cue that alerts them to press a button as fast as possible.

Who Took Part

117 actual participants took part.

It was open to people of any sex aged from 45 years up to 89 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 45-89 years old. English, Spanish, or multilingual speakers. Postmenopausal or surgically sterile females only.

The full record lists 7 inclusion and 18 exclusion criteria; among the exclusions: pregnancy or breastfeeding; contraindication for mri (claustrophobia and magnetic metal implants); glucose-6-phosphate deficiency, methemoglobinemia.

How the Study Was Run

Design: randomized, single-group and quadruple-blind.

The participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

Neither the participants nor the staff measuring them knew who was on Methylene blue (non-peptide stack partner), so expectations could not easily colour the readings.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-07 with completion listed for 2022-04-21.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): fMRI Measurement (time frame: baseline, 2 weeks and 12 weeks). Wechsler Memory Scale, Third Edition (time frame: baseline, 2 weeks ± 3 days, 12 weeks ± 3 days). fMRI During FNAME (time frame: baseline, 2 weeks ± 3 days,12 weeks ± 3 days).

It also tracked 1 secondary outcome, for example Cerebral Blood Flow Measures.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 117 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.