Efficacy and Safety of Lornoxicam in Patients With Mild to Moderate Probable Alzheimer´s Disease.
Condition: Alzheimer´s Disease
MeSH terms: Alzheimer Disease
Intervention: Lornoxicam; Placebo
Intervention description: Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.; Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
Intervention MeSH terms: Lornoxicam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 219.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No

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.
    

Eligibility 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