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Efficacy and Tolerability of MLC601 in Patients With Mild to Moderate Alzheimer Disease Who Were Unable to Tolerate or Failed to Benefit From Treatment With Rivastigmine

NCT ID: NCT01696123

Last Updated: 2012-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-08-31

Brief Summary

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Current therapeutic approaches for the treatment of neurodegenerative diseases like Alzheimer disease (AD) offer limited and often transient symptomatic benefits to patients but do not mitigate the insidious loss of neuronal cells. In this trial the investigators will evaluate Efficacy and Tolerability of MLC601 as a neuroprotective in Patients with Mild to Moderate Alzheimer Disease who Were Unable to Tolerate or Failed to Benefit from Treatment with Rivastigmine.

Detailed Description

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An 18-month open-label pilot study would be conducted at three university referral centres in Tehran, Iran. All patients are at least 50 years old, met the criteria for AD according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), and failed treatment with the cholinesterase inhibitor Rivastigmine for any reason. A baseline medical history will be taken and physical examination will be performed for all participants, and any comorbidities and concomitant therapies would be noted. Patients with controlled concomitant diseases, such as hypertension and diabetes, will be allowed to enter the study. Mini-Mental State Examination (MMSE)10 and Alzheimer disease assessment scale-cognitive sub scale11 (ADAS-cog) will be used to measure treatment efficacy. MLC601 will be prescribed as one capsule three times daily without an escalation dose. Safety and tolerability evaluations included physical examinations, electrocardiography, vital sign monitoring and laboratory testing weekly for the first 8 weeks and every 4 weeks thereafter. The MMSE and ADAS-cog will be recorded at each efficacy follow-up visit.

Conditions

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Alzheimer Disease

Keywords

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Alzheimer disease Cholinesterase inhibitors MLC601 NeuroAiD neuroprotection neuroregeneration

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MLC601

MLC601 (NeuroAid, Moleac Pte. Ltd, Singapore) (0.4 g per capsule) was prescribed as one capsule three times daily without an escalation dose.

Group Type EXPERIMENTAL

MLC601

Intervention Type DRUG

It was described

Interventions

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MLC601

It was described

Intervention Type DRUG

Other Intervention Names

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NeuroAid

Eligibility Criteria

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Inclusion Criteria

* at least 50 years old
* met the criteria for AD according to the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV)
* failed treatment with the cholinesterase inhibitor Rivastigmine for any reason

Exclusion Criteria

* uncontrolled diabetes mellitus
* hypertension
* unstable cardiac disease
* severe obstructive pulmonary disease
* renal or hepatic failure
* and/or other life threatening conditions
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Ali Amini Harandi

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Amini, M.D

Role: PRINCIPAL_INVESTIGATOR

Shahid Beheshti University of Medical Sciences, Tehran, Iran

Locations

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Loghman Hospital

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

References

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Pakdaman H, Amini Harandi A, Gharagozli K, Siavoshi F, Shirzadeh Barough S, Sharifipour E, Esfandani A, Ilkhani S, Tabatabaei FS, Sobhanian SA. A Long-term Study of NeuroAid (MLC601, MLC901) in Patients with Alzheimer's Disease; An Extension 8-year Follow-up Study. Curr Aging Sci. 2023;16(3):234-239. doi: 10.2174/1874609816666230224111759.

Reference Type DERIVED
PMID: 36843256 (View on PubMed)

Other Identifiers

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SBMU-1391

Identifier Type: -

Identifier Source: org_study_id