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Mycose AdminiStration for HealIng Alzheimer NEuropathy (MASHIANE) (MASHIANE)

Primary Purpose

Alzheimer Disease

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Trehalose
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer Disease, Trehalose, Clinical Trial, Autophagy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Mini-Mental State Examination (MMSE) score range from 10 to 23
  • Not having other cognitive disorders

Exclusion Criteria:

  • MMSE score higher than 23 or lower than 10
  • The presence of other cognitive disorders which will be evaluated by clinical assessment and brain imaging
  • The presence of factors affecting cognitive impairment such as depression
  • Vascular dementia and Lewy body dementia
  • Previous history of head trauma
  • Use of alcohol and other drugs that affect cognitive functioning

Sites / Locations

  • Ghaem Educational, Research and Treatment CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Trehalose

Placebo

Arm Description

Trehalose Participants will be received intravenous trehalose infusion weekly (15 g/week) for a period of 12 weeks.

Participants will be received equal volume of normal saline weekly for a period of 12 weeks.

Outcomes

Primary Outcome Measures

Changes of Mini-Mental State Exam (MMSE)
Global cognition will be assessed by MMSE test, which will be conducted at baseline and week 12.
Changes in Clinical Dementia Rating Scale (CDR)
Clinical Dementia Rating Scale (CDR) has six different cognitive and behavioral domains such as memory, orientation, judgment and problem solving, community affairs, home and hobbies performance, and personal care, which will be conducted at baseline and week 12.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2020
Last Updated
December 5, 2020
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04663854
Brief Title
Mycose AdminiStration for HealIng Alzheimer NEuropathy (MASHIANE)
Acronym
MASHIANE
Official Title
Evaluation of the Therapeutic Effects of Trehalose in Patients With Alzheimer Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2020 (Actual)
Primary Completion Date
March 20, 2022 (Anticipated)
Study Completion Date
August 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Alzheimer's disease (AD) is an irreversible, progressive brain disorder that slowly destroys memory and thinking skills, and, eventually, the ability to function independently. Despite the significant effort to understand the basic biology of the disease and pharmaceutical advances to develop drugs, there is no effective therapy available to treat AD or slow the disease progression. β-amyloid accumulation outside brain cells and abnormal accumulations of tau protein inside neurons are taught to be two main changes in the brain that lead to AD. Progressive accumulation of β-amyloid interferes with the neuron-to-neuron communication at synapses, contributing to neural cell death. Also, tau tangles block the transport of nutrients and other essential molecules into the neurons. Many molecules have been shown to inhibit amyloid aggregation. The anti-amyloidogenic activity of trehalose was confirmed in both in vitro and in vivo studies and its inhibitory effects on β-amyloid formation in AD have also been demonstrated. Trehalose is a non-toxic disaccharide and no dose-dependent adverse effects were seen in any of the safety studies. It can act as a chemical chaperone and stabilizes the natively folded structure of protein and also trehalose has been identified as an autophagy inducer and promotes the clearance of aggregated proteins. Therefore, trehalose could be a valuable candidate for the treatment and prevention of amyloid-related disease. Based on the proposed hypothesis, this study aim to investigate the potential efficacy of trehalose administration in patients with AD.
Detailed Description
Purpose of the study: A randomized, triple-blind, pilot clinical trial has been designed to evaluate the effectiveness of trehalose on reducing the symptoms in AD patients. Study intervention: twenty patients with Alzheimer's disease were randomly divided into an intervention and a control group. Trehalose will be administrated intravenously (15 g/week) for 12 weeks in the intervention group and the control group will be received normal saline as a placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer Disease, Trehalose, Clinical Trial, Autophagy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trehalose
Arm Type
Experimental
Arm Description
Trehalose Participants will be received intravenous trehalose infusion weekly (15 g/week) for a period of 12 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be received equal volume of normal saline weekly for a period of 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Trehalose
Other Intervention Name(s)
Mycose
Intervention Description
Trehalose is a natural disaccharide sugar found extensively among miscellaneous organisms including bacteria, plants, insects, yeast, fungi, and invertebrates. By preventing protein denaturation, it plays various protective roles against stress conditions such as heat, freeze, oxidation, desiccation and dehydration. Owing to this capacity, trehalose is an FDA-approved pharmaceutical excipient that is used as a stabilizer in numerous medicines including parenteral products. In this study, all injections will be conducted by a trained nurse in the presence of a specialist physician at a duration of 45-90 minutes.
Primary Outcome Measure Information:
Title
Changes of Mini-Mental State Exam (MMSE)
Description
Global cognition will be assessed by MMSE test, which will be conducted at baseline and week 12.
Time Frame
From baseline to 12 weeks
Title
Changes in Clinical Dementia Rating Scale (CDR)
Description
Clinical Dementia Rating Scale (CDR) has six different cognitive and behavioral domains such as memory, orientation, judgment and problem solving, community affairs, home and hobbies performance, and personal care, which will be conducted at baseline and week 12.
Time Frame
From baseline to 12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mini-Mental State Examination (MMSE) score range from 10 to 23 Not having other cognitive disorders Exclusion Criteria: MMSE score higher than 23 or lower than 10 The presence of other cognitive disorders which will be evaluated by clinical assessment and brain imaging The presence of factors affecting cognitive impairment such as depression Vascular dementia and Lewy body dementia Previous history of head trauma Use of alcohol and other drugs that affect cognitive functioning
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amirhossien Sahebkar, PhD
Phone
+985138002299
Email
SahebkarA@mums.ac.ir
Facility Information:
Facility Name
Ghaem Educational, Research and Treatment Center
City
Mashhad
State/Province
Razavi Khorasan
ZIP/Postal Code
9919991766
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amirhossein Sahebkar, PharmD, PhD
Phone
+989151221496
Email
sahebkara@mums.ac.ir

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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Results Reference
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23305823
Citation
Prince M, Bryce R, Albanese E, Wimo A, Ribeiro W, Ferri CP. The global prevalence of dementia: a systematic review and metaanalysis. Alzheimers Dement. 2013 Jan;9(1):63-75.e2. doi: 10.1016/j.jalz.2012.11.007.
Results Reference
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PubMed Identifier
25984581
Citation
Alzheimer's Association. 2015 Alzheimer's disease facts and figures. Alzheimers Dement. 2015 Mar;11(3):332-84. doi: 10.1016/j.jalz.2015.02.003.
Results Reference
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PubMed Identifier
14685252
Citation
Cohen FE, Kelly JW. Therapeutic approaches to protein-misfolding diseases. Nature. 2003 Dec 18;426(6968):905-9. doi: 10.1038/nature02265.
Results Reference
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PubMed Identifier
9686307
Citation
Teplow DB. Structural and kinetic features of amyloid beta-protein fibrillogenesis. Amyloid. 1998 Jun;5(2):121-42. doi: 10.3109/13506129808995290.
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PubMed Identifier
23477989
Citation
Villemagne VL, Burnham S, Bourgeat P, Brown B, Ellis KA, Salvado O, Szoeke C, Macaulay SL, Martins R, Maruff P, Ames D, Rowe CC, Masters CL; Australian Imaging Biomarkers and Lifestyle (AIBL) Research Group. Amyloid beta deposition, neurodegeneration, and cognitive decline in sporadic Alzheimer's disease: a prospective cohort study. Lancet Neurol. 2013 Apr;12(4):357-67. doi: 10.1016/S1474-4422(13)70044-9. Epub 2013 Mar 8.
Results Reference
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PubMed Identifier
20920466
Citation
Izmitli A, Schebor C, McGovern MP, Reddy AS, Abbott NL, de Pablo JJ. Effect of trehalose on the interaction of Alzheimer's Abeta-peptide and anionic lipid monolayers. Biochim Biophys Acta. 2011 Jan;1808(1):26-33. doi: 10.1016/j.bbamem.2010.09.024. Epub 2010 Oct 1.
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PubMed Identifier
24236985
Citation
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PubMed Identifier
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Arora A, Ha C, Park CB. Inhibition of insulin amyloid formation by small stress molecules. FEBS Lett. 2004 Apr 23;564(1-2):121-5. doi: 10.1016/S0014-5793(04)00326-6.
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PubMed Identifier
14730359
Citation
Tanaka M, Machida Y, Niu S, Ikeda T, Jana NR, Doi H, Kurosawa M, Nekooki M, Nukina N. Trehalose alleviates polyglutamine-mediated pathology in a mouse model of Huntington disease. Nat Med. 2004 Feb;10(2):148-54. doi: 10.1038/nm985. Epub 2004 Jan 18.
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Citation
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Mycose AdminiStration for HealIng Alzheimer NEuropathy (MASHIANE)

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