Mycose AdminiStration for HealIng Alzheimer NEuropathy (MASHIANE) (MASHIANE)
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| ClinicalTrials.gov Identifier: NCT04663854 |
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Recruitment Status :
Recruiting
First Posted : December 11, 2020
Last Update Posted : December 11, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer Disease | Drug: Trehalose | Phase 1 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Evaluation of the Therapeutic Effects of Trehalose in Patients With Alzheimer Disease |
| Actual Study Start Date : | August 20, 2020 |
| Estimated Primary Completion Date : | March 20, 2022 |
| Estimated Study Completion Date : | August 20, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Trehalose
Trehalose Participants will be received intravenous trehalose infusion weekly (15 g/week) for a period of 12 weeks.
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Drug: Trehalose
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.
Other Name: Mycose |
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Placebo Comparator: Placebo
Participants will be received equal volume of normal saline weekly for a period of 12 weeks.
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Drug: Trehalose
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.
Other Name: Mycose |
- Changes of Mini-Mental State Exam (MMSE) [ Time Frame: From baseline to 12 weeks ]Global cognition will be assessed by MMSE test, which will be conducted at baseline and week 12.
- Changes in Clinical Dementia Rating Scale (CDR) [ Time Frame: From baseline to 12 weeks ]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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663854
| Contact: Amirhossien Sahebkar, PhD | +985138002299 | SahebkarA@mums.ac.ir |
| Iran, Islamic Republic of | |
| Ghaem Educational, Research and Treatment Center | Recruiting |
| Mashhad, Razavi Khorasan, Iran, Islamic Republic of, 9919991766 | |
| Contact: Amirhossein Sahebkar, PharmD, PhD +989151221496 sahebkara@mums.ac.ir | |
| Responsible Party: | Amirhossein Sahebkar, Associate Professor at Mashhad University of Medical Sciences, Mashhad University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT04663854 |
| Other Study ID Numbers: |
971659 |
| First Posted: | December 11, 2020 Key Record Dates |
| Last Update Posted: | December 11, 2020 |
| Last Verified: | December 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Alzheimer Disease Trehalose Clinical Trial Autophagy |
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |