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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 28, 2014