Health Condition 1: G319- Degenerative disease of nervous system, unspecified
Conditions
Interventions
None listed
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: a. Subjects of either sex, aged 45 years to 75 years b. Subjects diagnosed with mild cognitive impairment or early Alzheimer disease by the consulting neurologist at AIIMS, New Delhi based on NIA-AA diagnostic criteria c. Patients willing to participate in the study, who give informed written consent and are able to comply with the study requirements d. Subjects who are able to read and comprehend Hindi and English language properly for comprehending the cognitive assessments tests. e. Participant should have at least 5 years of formal education.
Exclusion criteria
Exclusion criteria: a. Subjects with advanced malignancies, significant systemic diseases like chronic kidney diseases, severe hepatic, pulmonary, cardiac disease and other neurologic diseases or drugs that are known to affect cognition, like structural brain lesions, stroke, epilepsy, traumatic brain injury,Parkinson disease,Parkinson plus syndromes, and normal pressure hydrocephalus, autoimmune or paraneoplastic encephalitis b. Patients of clinically diagnosed major psychiatric disorder (e.g., psychosis, major depression, bipolar disorder). c.Use of psychoactive medications that would affect subject’s ability to reliably perform neuro-cognitive testing d. Visual / auditory impairment that would preclude the participant from participating in or cooperating with the protocol e. History of intake of Bacopa monnieri or any other investigational drug or on cholinesterase inhibitors within 1 month prior to screening visit. f. Subjects with alcohol use as defined by National Institute on Alcohol Abuse and Alcoholism (NIAAA) g. Participants who have undergone a major surgical procedure in the last six months, or whose TSH is not more than 10 microunits per millilitre at the time of enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the composite Z score of episodic memory (including the following scores of Learning Over Trials, Delayed Recall, Delayed recognition of word lists, immediate recall, free recall, cued recall and spatial recall of TNI - 93) in the two groups.Timepoint: Baseline and completion of 12th week | — |
Secondary
| Measure | Time frame |
|---|---|
| Identification of metabolites, pathways and networks in MCI or early AD patients after administration of Bacopa monnieri LinnTimepoint: Baseline and 12 weeks;Change in composite z score of episodic memory in the two groupsTimepoint: after completion of 24th week;Change in composite z score of other cognitive domains (attention, executive functions, visuospatial ability and information processing speed)Timepoint: after completion of 12th week and 24th week;Proportion of patients with clinically significant improvement (defined as either more than or equal to 5 points improvement in ACE-III, OR more than or equal to 0.5 unit improvement in composite episodic memory z score OR statistically significant change in the ACE-III score) in the two groupsTimepoint: after completion of the 12th week & 24th week;Frequency of self reported adverse events in the two groupsTimepoint: from baseline to completion of 12th week) | — |
Countries
India
Contacts
Public ContactDr Anu Gupta
All India Institute of Medical Sciences (AIIMS), New Delhi
Outcome results
None listed