Health Condition 1: G309- Alzheimers disease, unspecified
Conditions
Interventions
Intervention1: Dexketoprofen trometamol: Dexketoprofen trometamol 75mg SR vs placebo given to patients with Alzheimers disease along with standard of care for a period of 9 months
Control Intervention
Sponsors
Amrita Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: Age sixty years or older Diagnosis of Alzheimers disease according to the revised National Institute on Aging and Alzheimers Association criteria of 2024, clinical stage three to five On a stable dose of approved Alzheimers disease medications such as donepezil or memantine for at least three months before enrollment Availability of a reliable caregiver able to support study participation, attend study visits, and report treatment compliance Adequate hepatic function defined as aspartate aminotransferase and alanine aminotransferase not more than two point five times the upper limit of normal, and total bilirubin not more than one point five times the upper limit of normal Adequate renal function defined as creatinine clearance of fifty milliliters per minute or more calculated using the Cockcroft Gault method Written informed consent obtained from the participant where decision making capacity allows and from a legally authorized representative
Exclusion criteria
Exclusion criteria: Severe dementia (stage greater than 5, NIA-AA 2024). Presence of other neurodegenerative disorders (e.g., Parkinson s or Huntington s disease). Hypersensitivity to NSAIDs or history of NSAID-induced gastrointestinal complications. Active peptic ulcer disease, GI bleeding, severe renal/hepatic/cardiac dysfunction. Chronic use of NSAIDs (other than study drug), corticosteroids, anticoagulants, or immunosuppressants within 4 weeks prior to enrollment. Severe psychiatric comorbidities (schizophrenia, bipolar disorder) interfering with participation. Substance or alcohol dependence in the last 5 years. Participation in another interventional trial within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Addenbrooke s Cognitive Examination (ACE) total score from baseline assessed using the ACE scale at 3 months, 6 months, and 9 months after interventionTimepoint: 3 months, 6 months, and 9 months after intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrumental Activities of Daily Living-Elderly (IADL-E), QoL SF-36 (RAND-36), Neuropsychiatriac inventory (NPI), Geriatric depression scale (GDS) and Amyloid beta 42/40 ratio, phosphorylated tau (p-tau), glial fibrillary acidic protein (GFAP), neurofilament light chain (NfL) and BH4/BH2 ratio will be assessed using serum isolated from the blood samplesTimepoint: 3 months, 6 months, and 9 months after intervention | — |
Countries
India
Contacts
Public ContactSudheeran Kannoth
Amrita school of nanoscience and molecular medicine,Amrita Institute of Medical Sciences
Outcome results
None listed