Health Condition 1: G300- Alzheimers disease with early onset
Conditions
Interventions
Intervention1: Glutathione: Oral,
500mg once a day (OD) for 6 months
Control Intervention1: Placebo: Oral,
500mg once a day (OD) for 6 months
Sponsors
National Brain Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. i. Memory - Rey Complex Figure test (Delayed Recall and recognition) ii. Visuo-spatial functioning- Clock Drawing test and Rey Complex Figure test (Copy) iii. Attention - Trail Making Test ââ?¬â?? A and Digit span forwards (WAIS-IV) 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) | — |
Countries
India
Contacts
Public ContactDr Pravat Kumar Mandal
National Brain Research Centre
Outcome results
None listed