Memory Improvement by Glutathione Supplementatio
- Conditions
- Health Condition 1: G300- Alzheimers disease with early onset
- Registration Number
- CTRI/2020/09/027645
- Lead Sponsor
- ational Brain Research Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
i. Patients diagnosed with amnestic MCI.
ii. Acceptance of taking the supplements as directed and compliant to follow-up data assessment.
iii. Screening Tests:
a. Standardized mini-mental state examination (SMMSE) score should be obtained between 20 to 25.
b. Clinical dementia rating (CDR) scale should be equal to 0.5.
c. MRI safety screening test to be performed before undergoing for MRI procedure.
iv. Participants should be able to understand as well as speak Hindi or English.
i. Participants with any metallic implants or claustrophobic or having any contraindication to MRI and MRS.
ii. Patients suffering from any severe acute or chronic comorbid condition (COPD, chronic cardiovascular diseases, chronic liver disease, chronic kidney disease or any immunological disorder, etc.).
iii. Patients with any other neurological or neuropsychological, or psychiatric illness (other than primary indication).
iv. Participants with known hypersensitivity to any component of the GSH supplement.
v. Participants undertaking any other antioxidant within 90 days prior to the enrolment.
vi. Participants with whom compliance with follow-up is unlikely.
vii. Participants who are not willing to give consent will also be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measurement of brain GSH level quantification level in the brain frontal cortices and hippocampus region after supplementation and washout of the oral GSH compared to placebo among MCI patients using MRS technique.Timepoint: Baseline (0th month), 1st Follow-up (After 3 months intervention), 2nd Follow-up (After 6 months intervention) and 3rd Follow-up (After 6 months washout)
- Secondary Outcome Measures
Name Time Method Measurement of brain iron deposition level after supplementation and washout in both the groups using the QSM techniqueTimepoint: Baseline (0th month), 1st Follow-up (After 3 months intervention), 2nd Follow-up (After 6 months intervention) and 3rd Follow-up (After 6 months washout);Measurement of Neuropsychological tests after supplementation and washout in both groups. <br/ ><br>i. Memory - Rey Complex Figure test (Delayed Recall and recognition) <br/ ><br>ii. Visuo-spatial functioning- Clock Drawing test and Rey Complex Figure test (Copy) <br/ ><br>iii. Attention - Trail Making Test ââ?¬â?? A and Digit span forwards (WAIS-IV) <br/ ><br>iv. Executive functioning - Trail Making Test ââ?¬â?? B, Digit Span backward and sequencing (WAIS-IV) and Stroop testTimepoint: Baseline (0th month), 1st Follow-up (After 3 months intervention), 2nd Follow-up (After 6 months intervention) and 3rd Follow-up (After 6 months washout)