Alzheimer Disease
Conditions
Keywords
Alzheimer disease, Cholinesterase inhibitors, MLC601, NeuroAiD, neuroprotection, neuroregeneration
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.
Detailed description
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.
Interventions
DRUGMLC601
It was described
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in the Mini-Mental State Examination (MMSE) relative to baseline measurements | every 4 weeks up to 18 months | change in the Mini-Mental State Examination (MMSE) relative to baseline measurements will be evaluated every 4 weeks up to 18 months. |
| changes in the cognitive subscale of the AD Assessment Scale (ADAS-cog) relative to baseline measurements | every 4 weeks up to 18 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| to measure included adverse events (AEs) | every 4 weeks | 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. AEs were defined as any sign, symptom, syndrome or disease that occurred for the first time or worsened after baseline, whether they were considered treatment related. |
| measuring withdrawal rate | every 4 weeks | measuring any withdrawal rate among intervention group |
Countries
Iran
Outcome results
None listed