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Role of Brahmi in treatment of Alzheimers disease

Efficacy of (Bacopa Monnieri) and Donepezil in Alzheimer disease patients: A randomized double-blind parallel phase 2b study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/04/013388
Enrollment
48
Registered
2018-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Alzheimerâ??s disease, Mild Cognitive Impairment-AD

Interventions

Intervention1: Bacopa monnieri(brahmi): 300 mg OD for one year Control Intervention1: Donepezil: 10 mg OD for one year

Sponsors

Postgraduate Institute of Medical Education and Research
Lead Sponsor
Dr Manish Modi
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age > 50 yrs 2. DSM IV Criteria for Dementia 3. Diagnostic criteria for MCI, AD (Duboisâ??s criteria), VaD (DSM IV TR) 4. Study informant available 5. Adequate vision and hearing for neuropsychological testing 6. Normal appropriate laboratory tests 7. All subjects and study informants signed written consent

Exclusion criteria

Exclusion criteria: 1. Young onset dementia 2. Diagnosis of vascular dementia, Fronto-temporal dementia 3. Secondary acquired causes of dementia

Design outcomes

Primary

MeasureTime frame
Change in dementia rating scales (Alzheimerâ??s Disease Assessment Scale (Cognitive) and PGI (Postgraduate Institute) Memory scale at 3,6,9 and 12 monthsTimepoint: 4 years

Secondary

MeasureTime frame
Verbal fluency â?? Controlled oral word test (phonemic) & Animal Names test (categorical), Quality of life â?? AD, ADCS (Alzheimerâ??s Disease Cooperative Study) Activities of Daily Living Inventory, Compliance to treatment and number of adverse eventsTimepoint: 4 years

Countries

India

Contacts

Public ContactManish Modi

Former Head of Department

sudeshprabhakar@gmail.com9815606691

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026