Health Condition 1: F70- Mild intellectual disabilities
Conditions
Interventions
None listed
Sponsors
Central Council For Research In Ayurvedic Sciences CCRAS Ministry of Ayush Government of India
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age between 45 and 75 years of either sex 2.Diagnosis of mild neurocognitive disorder (MNCD) due to AD as per DSM-5 criteria 3.CDR score less or equal to 2 4.Montreal Cognitive Assessment (MoCA) score between 17 and 24 indicating mild cognitive impairment 5.Amyloid positivity confirmed by PET imaging 6.HMSE score is 18 to26 7.ACE-III score is 60 to 82 8.No cerebrovascular abnormalities or contraindicated brain pathology on MRI 9.Presence of a family member or informal caregiver to assist the participant 10.Willingness to participate in the study for a period of 9 months with written informed consent
Exclusion criteria
Exclusion criteria: 1.Clinical Dementia Rating (CDR) Scale score more than 2 indicating the presence of dementia beyond mild neurocognitive disorder (MNCD) 2.Cognitive impairment accompanied by significant behavioral or psychiatric symptoms including psychosis major mood disturbances agitation apathy or other neurobehavioral syndromes likely to interfere with cognitive assessment or study compliance 3.Diagnosis of major neurocognitive disorder severe psychiatric illnesses (schizophrenia bipolar disorder etc) or other established neuropsychiatric conditions known to affect cognition 4.Current or past dependence on psychoactive substances including antipsychotics benzodiazepines opioids recreational drugs or a history of substance abuse (including alcohol and illicit drugs) within the past year 5 Presence of any active malignancy or history of malignancy under active surveillance or treatment. 6.Presence of systemic illnesses that may influence neurological or cognitive functioning including diabetes mellitus with HbA1c more than 8 percent Uncontrolled hypertension defined as systolic blood pressure equal or more than 140 mmHg and or diastolic blood pressure equal or more than 90 mmHg on repeated measurements significant hepatic dysfunction (AST and or ALT greater than three times the upper limit of normal) renal impairment (serum creatinine more than 1.4 mg per dL) and pulmonary dysfunction 7.Metabolic or endocrine conditions known to affect cognition such as Vitamin B12 deficiency and hypothyroidism unless adequately corrected and stabilized 8.Diagnosis of any primary neurological disorder that could confound study assessments including but not limited to vascular dementia parkinson s disease post-stroke cognitive impairment multiple sclerosis huntington s disease prion diseases etc 9.Individuals with neurological sequelae of head trauma epilepsy or autoimmune encephalopathies that may affect neurocognitive evaluation 10.Individuals who reside outside of Bengaluru or are unable to commit to regular follow-up due to geographic or logistic constraints 11.Known contraindications to Amyloid PET-MRI imaging including implanted cardiac pacemakers metallic orthopedic implants aneurysm clips or other non-MRI compatible medical devices
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in cognitive function from baseline, as assessed by the Montreal Cognitive Assessment (MoCA) score.Timepoint: Baseline, Day 90, Day 180, and Day 270 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in cognitive function from baseline, assessed using the Clinical Dementia Rating Scale (CDR-SB) scaleTimepoint: .[Time frame: at Baseline, 90th day, 180th day and 270th day (at the end of the treatment);Mean change in scores on the Addenbrooke s Cognitive Examination (ACE-III) from baseline.Timepoint: [Time Frame: Baseline, Day 180, and Day 270];Mean changes in Hindi Mental Status Examination (HMSE) from baseline.Timepoint: [Time Frame: Baseline, Day 180, and Day 270];Change in total and domain-specific scores on the Neuropsychiatric Inventory (NPI).Timepoint: [Time Frame: Baseline, Day 180, and Day 270];Incidence and severity of adverse events (AEs) and serious adverse events (SAEs); changes in routine hematological and biochemical parameters.Timepoint: (baseline to day 270 for AE/ADR and lab investigations on baseline, 90, 180, and 270);Proportion of participants withdrawing (dropping out) from the study due to treatment-emergent adverse events. Patient reported treatment adherence and compliance through diary logs and patient returned medicine bottles as appropriate for each formulation. Timepoint: [Time Frame: Baseline, Day 180] | — |
Countries
India
Contacts
Public ContactDr Kishore Kumar R
NIMHANS
Outcome results
None listed