A clinical trial to test the safety and effectiveness of Neuralzhein in management of memory loss related to age.
- Conditions
- Health Condition 1: F54- Psychological and behavioral factors associated with disorders or diseases classified elsewhere
- Registration Number
- CTRI/2019/08/020711
- Lead Sponsor
- exxus Laboratories DBA OPUS PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
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
11.Personality changes
12.Inability to perform daily activities
13. Disorientation and reduced eye movement.
14. Visual perception & auditory recognition capacity.
15. Subjects with Mini-Mental State Examination (MMSE) score of 13 to 24
16. Subjects with Modified Hachinski Ischemic Scale (MHIS) score of �¬�¬�¬�¬ 4 or less.
17. The subjects having an identified, reliable, study partner (care giver) who is able to read, write and understand the study procedures and can attend study appointments. The caregiver should have the ability to answer questions about the subjectââ?¬•s behavior, activity of daily living, quality of life, and their own level of stress. The compliance card has to be filled by the caregiver.
18. Subjects newly diagnosed with dementia who are willing to participate into the study, subjects who have not shown any improvement with other medications or subjects who are ready to quit the ongoing treatment and ready to start IP.
19. Subjects must have gradual and progressive change in memory function for >6 months.
20. Subjects who are willing to undergo MRI if required.
21. Subjects should have adequate visual and auditory acuity to allow neuropsychological testing.
22.Subjects who will be able to travel to the research site without being non-compliant with the visits and procedures.
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.
10. Terminal illness (i.e., life expectancy < 1 year)
11. Participation in another research study that could potentially confound current study (e.g., medication or behavioral intervention)
12. History of head trauma associated with injury-onset cognitive complaints or loss of consciousness for 10 minutes or longer.
13. Women with Child bearing capabilities.
14. Subjects taking sedative, antidepressants or antipsychotics
15. Any surgical procedure in the recent time.
16. Any autoimmune disorders.
17. Febrile patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in the scores of ACE (R) from baseline to last visit. <br/ ><br>2. Change in the scores of MHIS from baseline to last visit. <br/ ><br>Timepoint: 3 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1. To know the occurrence of the safety part in case of Adverse Drug Reactions,Adverse Events or Serious Adverse Events. <br/ ><br>2. To measure the quality of life of patients with the help of QOL questionnaire from the baseline till the last visit.Timepoint: 3 Months