Alzheimer´s Disease Clinical Trial
Official title:
A Multicentre Double-blind, Placebo-controlled, Randomised, Parallel-group Study to Evaluate the Efficacy and Safety of Lornoxicam in Patients With Mild to Moderate Probable Alzheimer´s Disease.
Study title: A multicentre double-blind, placebo-controlled, randomised, parallel-group
study to evaluate the safety and efficacy of Lornoxicam in patients with mild to moderate
probable Alzheimer's Disease.
Study phase: II
Indication: Alzheimer´s Disease
Investigational product, dose schedule and route of administration: Lornoxicam (8 mg)
tablets to be taken orally two times daily (BID) for a period of 6 months.
Reference product, dose, schedule and route of administration: Placebo (8 mg) tablets to be
taken orally two times daily (BID) for a period of 6 months.
Status | Terminated |
Enrollment | 219 |
Est. completion date | April 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years to 85 Years |
Eligibility |
Inclusion Criteria: 1. Men and women (non-childbearing potential) with a diagnosis of Alzheimer's Disease according to the NINCDS-ADRDA clinical criteria. 2. Mild to moderate stage of Alzheimer's disease according to MMSE 18-26 inclusive. 3. Modified Hachinski Ischemic Scale equal to or below 4. 4. Geriatric Depression Scale below or equal 7. 5. If anticholinesterasic treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 1). 6. If Memantine treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 1). Exclusion criteria: 1. Clinical, laboratory or neuroimaging findings consistent with: - other primary degenerative dementia, (dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, Jacob-Creutzfeld Disease, Down's syndrome, etc.) - other neurodegenerative condition (Parkinson's Disease, amyotrophic lateral sclerosis, etc.) - cerebrovascular Disease (major infarct, one strategic or multiple lacunar infarcts, extensive white matter lesions > one quarter of the total white matter) - other central nervous system diseases (severe head trauma, tumors, subdural haematoma or other space occupying processes, etc.) - seizure disorder - other infectious, metabolic or systemic diseases affecting central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency confirmed by current analyses not older than 1 month, serum electrolytes out of normal range, juvenile onset diabetes mellitus, etc.) 2. A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder. 3. Chronic daily drug intake for a time period of = 14 days or expected for = 14 days: " - antidepressants, benzodiazepines, neuroleptics, major sedatives or other anti-inflammatory drugs including acetylic salicylic acid defined - antiepileptics - anticholinergics - nootropics (including Ginkgo) - centrally active anti-hypertensive drugs (clonidine, alpha-methyl dopa, guanidine, guanfacine,) - opioid containing analgesics - anti-inflammatory agents, cortico-steroids or immunosuppressants - Cimetidin as gastroprotective drug 4. Severe thrombocytopenia defined as platelet counts <100.000 per mm3. 5. Coagulation disorders |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
JSW Lifesciences |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive Performance - ADAS-cog+ | Alzheimer's disease Assessment Scale, Cognitive Subscale (15 item) Higher scores indicate cognitive impairment. All items are assessed by independent rater (psychologists). The score goes from 0 points (no cognitive impairment) to 95 points (maximum impairment in all 15 items). Primary Outcome Measure is the change from baseline ADAS-cog+ score to the score after 26 weeks (end of double blind). |
6 months double blind, 6 months open-label (optional) | No |
Secondary | Activities of Daily Living - ADCS-ADL; Behavioral/Psychiatric Symptoms - NPI | 6 months double-blind, 6 months open label (optional) | No |
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