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Study · Randomized controlled trial · 2015

5 results

Tau aggregation inhibitor therapy: an exploratory phase 2 study in mild or moderate Alzheimer's disease.

Wischik CM, Staff RT, Wischik DJ, Bentham P, Murray AD, Storey JM, Kook KA, Harrington CR

Journal of Alzheimer's disease : JAD1 Jan 2015Cited by 197 (Europe PMC)

PMID25550228 (opens in a new tab)DOI10.3233/jad-142874 (opens in a new tab)PepBankPUB-25550228
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In moderate Alzheimer's disease, methylthioninium improved ADAS-cog scores versus placebo.

    In plain wordsIn patients with moderate Alzheimer's disease, methylthioninium improved cognitive scores compared with placebo.

    Peptide
    Methylene blue
    Outcome
    DecreaseADAS-cog in moderate Alzheimer's disease
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    138 mg/day · 24 weeksAs given in this study (human).

    Measurements

    ADAS-cog treatment effect
    −5.42 units
    moderate AD, 138 mg/day vs placebo, 24 weeks

    Source sentences

    Summary
    At 24 weeks, there were significant treatment benefits in two independent populations at the 138 mg/day dose: in moderate subjects on the ADAS-cog scale (treatment effect: -5.42 units, corrected p = 0.047) and two other clinical scales
    1 context sentence
    Summary · context
    An exploratory double-blind, randomized, placebo-controlled, dose-finding trial of MT (69, 138, and 228 mg/day) was conducted in 321 mild/moderate AD subjects.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In mild Alzheimer's disease, methylthioninium benefited regional cerebral blood flow versus placebo.

    In plain wordsIn patients with mild Alzheimer's disease, methylthioninium benefited brain blood flow compared with placebo.

    Peptide
    Methylene blue
    Outcome
    IncreaseRegional cerebral blood flow in mild Alzheimer's disease
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Neuroprotection · Nervous system and cognition
    Studied dose
    138 mg/day · 24 weeksAs given in this study (human).

    Measurements

    Regional cerebral blood flow treatment effect
    1.97%
    mild AD, 138 mg/day vs placebo, 24 weeks

    Source sentences

    Summary
    At 24 weeks, there were significant treatment benefits in two independent populations at the 138 mg/day dose: in moderate subjects on the ADAS-cog scale (treatment effect: -5.42 units, corrected p = 0.047) and two other clinical scales; in mild subjects on the more sensitive regional cerebral blood…
    1 context sentence
    Summary · context
    An exploratory double-blind, randomized, placebo-controlled, dose-finding trial of MT (69, 138, and 228 mg/day) was conducted in 321 mild/moderate AD subjects.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In mild Alzheimer's disease, continued methylthioninium treatment showed ADAS-cog benefit.

    In plain wordsIn patients with mild Alzheimer's disease, continued methylthioninium treatment showed cognitive benefit.

    Peptide
    Methylene blue
    Outcome
    DecreaseADAS-cog in mild Alzheimer's disease at 50 weeks
    Study

    n: not reported in source

    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    Dose not stated · 50 weeksAs given in this study (human).

    Source sentences

    Summary
    With continued treatment for 50 weeks, benefit was seen on the ADAS-cog scale in both mild and moderate subjects.
    1 context sentence
    Summary · context
    An exploratory double-blind, randomized, placebo-controlled, dose-finding trial of MT (69, 138, and 228 mg/day) was conducted in 321 mild/moderate AD subjects.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In moderate Alzheimer's disease, continued methylthioninium treatment showed ADAS-cog benefit.

    In plain wordsIn patients with moderate Alzheimer's disease, continued methylthioninium treatment showed cognitive benefit.

    Peptide
    Methylene blue
    Outcome
    DecreaseADAS-cog in moderate Alzheimer's disease at 50 weeks
    Study

    n: not reported in source

    Outcome group
    Cognition and memory · Nervous system and cognition
    Studied dose
    Dose not stated · 50 weeksAs given in this study (human).

    Source sentences

    Summary
    With continued treatment for 50 weeks, benefit was seen on the ADAS-cog scale in both mild and moderate subjects.
    1 context sentence
    Summary · context
    An exploratory double-blind, randomized, placebo-controlled, dose-finding trial of MT (69, 138, and 228 mg/day) was conducted in 321 mild/moderate AD subjects.
  5. 05HumanRandomized controlled trialPharmacokinetics

    In Alzheimer's disease, dose-dependent dissolution and absorption limitations impaired delivery of the highest methylthioninium dose.

    In plain wordsIn patients with Alzheimer's disease, dissolution and absorption problems limited delivery of the highest methylthioninium dose.

    Peptide
    Methylene blue
    Outcome
    DecreaseHighest-dose delivery
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    228 mg/dayAs given in this study (human).

    Source sentences

    Summary
    The delivery of the highest dose was impaired due to dose-dependent dissolution and absorption limitations.
    1 context sentence
    Summary · context
    An exploratory double-blind, randomized, placebo-controlled, dose-finding trial of MT (69, 138, and 228 mg/day) was conducted in 321 mild/moderate AD subjects.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedNot applicableNCT04529265

Methylene Blue and Postoperative Neurocognitive Disorders

Fudan Universityn = 3141 May 2021 to 30 Dec 2024

Postoperative Delirium

Trial pageClinicalTrials.govUpdated 14 May 2025
CompletedPhase 2NCT00515333

TRx0014 in Patients With Mild or Moderate Alzheimer's Disease

TauRx Therapeutics Ltdn = 323Aug 2004 to Dec 2007

Dementia, Alzheimer Type

Trial pageClinicalTrials.govUpdated 20 Feb 2008

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    14 Oct 2026, 05:02 UTC

    Study results updated

  2. Version 1

    14 Oct 2026, 01:46 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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