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CompletedPhase 2

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

Lead sponsor

Shahid Beheshti University of Medical Sciences

Asset

MLC601

Listed sites

Recruiting sites

Enrollment

125

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥50

Primary endpoints

•Mini-Mental State Examination (MMSE)•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01696123

Org study IDSBMU-1391

Timeline

Milestones

Study start2011-01 (month precision)

Primary completion2012-01actual (month precision)

Study completion2012-08actual (month precision)

Study first posted2012-09-28estimated

Last update posted2012-09-28estimated

Assets

Drug assets

MLC601

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Safety / tolerability / PK

Other clinical outcomes

Global cognition

2 endpoints

Primary/protocol endpoint

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

Time frame:every 4 weeks up to 18 months

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Primary/protocol endpoint

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

Time frame:every 4 weeks up to 18 months

ADAS-Cog

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

to measure included adverse events (AEs)

Time frame:every 4 weeks

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

measuring withdrawal rate

Time frame:every 4 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
PMID36843256via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.