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

NCT01696123 | Completed Phase 2

• 1 other identifier: SBMU-1391
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer disease; Cholinesterase inhibitors; MLC601; NeuroAiD; neuroprotection; neuroregeneration

Outcome Measures

Primary Outcomes (2)

• changes in the Mini-Mental State Examination (MMSE) relative to baseline measurements

  change in the Mini-Mental State Examination (MMSE) relative to baseline measurements will be evaluated every 4 weeks up to 18 months.

  every 4 weeks up to 18 months

• changes in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements

  change in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements will be evaluated every 4 weeks up to 18 months.

  every 4 weeks up to 18 months

Secondary Outcomes (2)

• to measure included adverse events (AEs)

  every 4 weeks

• measuring withdrawal rate

  every 4 weeks

Study Arms (1)

MLC601

EXPERIMENTAL

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

Drug: MLC601

Interventions

MLC601 DRUG

It was described

Also known as: NeuroAid

MLC601

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Loghman Hospital

Tehran, Tehran Province, 1315693446, Iran

Location

Related Publications (1)

• 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.

  PMID: 36843256 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Neuroaid

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ali Amini, M.D

  Shahid Beheshti University of Medical Sciences, Tehran, Iran

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: September 28, 2012
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 28, 2012

Record last verified: 2012-09

Locations

IR (1)