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

NCT01117948 | Terminated Phase 2 Results DMC

• 1 other identifier: CR081101/CO14950
• Study Type: interventional
• Target: 219
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Alzheimer´s Disease

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Activities of Daily Living - ADCS-ADL; Behavioral/Psychiatric Symptoms - NPI

  6 months double-blind, 6 months open label (optional)

Study Arms (2)

Lornoxicam

EXPERIMENTAL

Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.

Drug: Lornoxicam

Placebo

PLACEBO COMPARATOR

Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.

Drug: Placebo

Interventions

Lornoxicam DRUG

Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.

Also known as: Xefo, Telos

Lornoxicam

Placebo DRUG

Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women (non-childbearing potential) with a diagnosis of Alzheimer's Disease according to the NINCDS-ADRDA clinical criteria.
• Mild to moderate stage of Alzheimer's disease according to MMSE 18-26 inclusive.
• Modified Hachinski Ischemic Scale equal to or below 4.
• Geriatric Depression Scale below or equal 7.
• If anticholinesterasic treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 1).
• If Memantine treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 1).

You may not qualify if:

• \. 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.
• \. 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

Sponsors & Collaborators

• JSW Lifesciences: lead

MeSH Terms

Interventions

lornoxicam

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: JSW-Lifesciences

office@jsw-lifesciences.com

0043316 258111

Study Officials

• Elisabeth Sterner, M.Sc.

  JSW-Life Sciences

  STUDY DIRECTOR

• Reinhold Schmidt, MD

  STUDY CHAIR

• Michael Rainer, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 6, 2010
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 6, 2013
• Results First Posted: November 29, 2012

Record last verified: 2013-02