CTRI/2019/08/020711
Completed
未知
A Prospective, Open label, multi-center Clinical Study to evaluate the efficacy and safety of Neuralzhein in management of Mild to Moderate age onset Dementia.
exxus Laboratories DBA OPUS PHARMA0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: F54- Psychological and behavioral factors associated with disorders or diseases classified elsewhere
- Sponsor
- exxus Laboratories DBA OPUS PHARMA
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subject should be able to give written consent for participation on their own or through their legally acceptable representative/Caregiver.
- •2\.Adult males or females aged between 55 years to 75 years with the diagnosis of any type of age onset Mixed Dementia Insulin resistance associated Diabetes Mellitus, Thyroid disorders, Vitamin B12 deficiency, Vitamin D deficiency.
- •3\.Subjects with following conditions will be recruited:
- •4\.Memory impairment (short term and long term), particularly recent events.
- •5\.Spatial arrangement recalls skills
- •6\. Mood swings
- •7\.Irritability, Inattentiveness, difficulty in focusing and apathy
- •8\.Speech impairment
- •9\. Reading and learning inability
- •10\. Sleep cycle changes
Exclusion Criteria
- •1\. Presence of non\-neurological medical conditions interfering with cognition.
- •2\. Subject having any contraindications or inability to tolerate brain magnetic resonance imaging (MRI) and Positron emission tomography (PET scans)
- •3\. Subject with history of myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions within 6 months of Screening.
- •4\. Subject having history of seizures.
- •5\. Subjects having significant neurological disease affecting the nervous system, other than dementia, that affects cognition or may affect completion of the study.
- •6\. Subjects having history of cancer within the last 5 years
- •7\. Subjects having serious risk for suicide.
- •8\. Subjects having history of drug or alcohol use disorder within the last 2 years.
- •9\. Subjects mustnââ?¬•t be immunocompromised, or have Hepatitis B or C.
- •Clinically significant uncontrolled medical or psychiatric illness Renal or liver impairment.
Outcomes
Primary Outcomes
Not specified
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