Efficacy and Safety of Lornoxicam in Patients With Mild to Moderate Probable Alzheimer´s Disease.

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JSW Lifesciences
• Treatments: Lornoxicam; Piroxicam

Criteria

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