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

This study has been terminated.
(Lack of Efficacy)
Sponsor:
Information provided by (Responsible Party):
JSW Lifesciences
ClinicalTrials.gov Identifier:
NCT01117948
First received: May 4, 2010
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer´s Disease
 Drug: Lornoxicam
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by JSW Lifesciences:

Primary Outcome Measures:
  • Cognitive Performance - ADAS-cog+ [ Time Frame: 6 months double blind, 6 months open-label (optional) ] [ Designated as safety issue: No ]

    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).



Secondary Outcome Measures:
  • Activities of Daily Living - ADCS-ADL; Behavioral/Psychiatric Symptoms - NPI [ Time Frame: 6 months double-blind, 6 months open label (optional) ] [ Designated as safety issue: No ]

Enrollment: 219
Study Start Date: September 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lornoxicam
Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
 Drug: Lornoxicam
Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
Other Names:
  • Xefo
  • Telos
Placebo Comparator: Placebo
Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
 Drug: Placebo
Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
Other Name: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01117948

Sponsors and Collaborators
JSW Lifesciences
Investigators
Study Director: Elisabeth Sterner, M.Sc. JSW-Life Sciences
Study Chair: Reinhold Schmidt, MD
Principal Investigator: Michael Rainer, MD
  More Information

No publications provided

Responsible Party: JSW Lifesciences
ClinicalTrials.gov Identifier: NCT01117948     History of Changes
Other Study ID Numbers: CR081101/CO14950
Study First Received: May 4, 2010
Results First Received: May 21, 2012
Last Updated: February 1, 2013
Health Authority: Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
Czech Republic: State Institute for Drug Control
Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Lornoxicam
Piroxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013