Potential of Low Dose Leuco-Methylthioninium Bis(Hydromethanesulphonate) (LMTM) Monotherapy for Treatment of Mild Alzheimer’s Disease: Cohort Analysis as Modified Primary Outcome in a Phase III Clinical Trial

Autor: Hans J Moebius, Charles S Davis, Jiri Hardlund, Kohkan Shamsi, Ken Marek, John Storey, Peter Bentham, Giovanni B. Frisoni, Serge Gauthier, Damon Wischik, Trevor Ahearn, Luc Bracoud, Vesna Vuksanović, Jianping Jia, Karin A Kook, Claude M. Wischik, Charles R. Harrington, Gernot Riedel, John Seibyl, Roger T. Staff, Bjoern Schelter, Gordon K. Wilcock
Rok vydání: 2017
Předmět:
Male
0301 basic medicine
Leuco-methylthioninium
amyloid protein
International Cooperation
Treatment outcome
Disease
Cohort Studies
0302 clinical medicine
Primary outcome
ADAS-cog
Aged
80 and over
treatment
General Neuroscience
Low dose
clinical trial
General Medicine
Middle Aged
Mental Status and Dementia Tests
Psychiatry and Mental health
Clinical Psychology
methylthioninium
Treatment Outcome
Adas cog
Female
Alzheimer’s disease
Research Article
Antipsychotic Agents
Cohort study
medicine.medical_specialty
tau protein
03 medical and health sciences
Double-Blind Method
Alzheimer Disease
Internal medicine
mental disorders
cohort study
medicine
Humans
Psychiatry
Aged
business.industry
Alzheimer Disease/diagnostic imaging/drug therapy
Methylene Blue
Clinical trial
030104 developmental biology
ddc:618.97
Geriatrics and Gerontology
business
Methylene Blue/analogs & derivatives/therapeutic use
Antipsychotic Agents/therapeutic use
030217 neurology & neurosurgery
Zdroj: Journal of Alzheimer's Disease, Vol. 61, No 1 (2018) pp. 435-457
Journal of Alzheimer's Disease
ISSN: 1875-8908
1387-2877
DOI: 10.3233/jad-170560
Popis: Background: LMTM is being developed as a treatment for AD based on inhibition of tau aggregation. Objectives: To examine the efficacy of LMTM as monotherapy in non-randomized cohort analyses as modified primary outcomes in an 18-month Phase III trial in mild AD. Methods: Mild AD patients (n = 800) were randomly assigned to 100 mg twice a day or 4 mg twice a day. Prior to unblinding, the Statistical Analysis Plan was revised to compare the 100 mg twice a day as monotherapy subgroup (n = 79) versus 4 mg twice a day as randomized (n = 396), and 4 mg twice a day as monotherapy (n = 76) versus 4 mg twice a day as add-on therapy (n = 297), with strong control of family-wise type I error. Results: The revised analyses were statistically significant at the required threshold of p
Databáze: OpenAIRE
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