Alzheimer´s DiseasePhase 2NCT01117948
Efficacy and Safety of Lornoxicam in Patients With Mild to Moderate Probable Alzheimer´s Disease.
A Phase 2 study testing Lornoxicam in people with Alzheimer´s Disease, run by JSW Lifesciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer´s Disease
- What is being tested?
- Lornoxicam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Apr 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 16Show fewer
- 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
About this study
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.
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.
Read the detailed description
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
Study objectives: Primary:
To evaluate the efficacy of Lornoxicam (8 mg, BID) administered for 6 months versus matched placebo based on the following end-point:
- Cognitive performance - ADAS-cog+
Secondary:
To evaluate the efficacy of Lornoxicam (8 mg, BID) administered for 6 months versus matched placebo based on the following end-point:
- Activities of daily living - ADCS-ADL
- Behavioral / psychiatric symptoms - NPI
To evaluate the safety of Lornoxicam (8 mg, BID) administered for 6 months versus matched placebo.
- Overall incidence of adverse events.
Exploratory:
In a subgroup of 50 patients MRI analyses will be performed. In a subgroup of 50 patients exploratory data on the production of amyloid biological markers - blood plasma concentration of Aß1-38, Aß1-40 and Aß1-42 will be collected.
An optional 6 month open-label phase will be available.
Subject population, diagnosis and main criteria for inclusion: Male and female patients with mild to moderate probable Alzheimer's Disease according to NINCDS-ADRDA criteria
- Age 50 - 85 years inclusive
- MMSE 18-26 inclusive
- No history of treatment with Acetylcholine-esterase inhibitors or 4 weeks wash out period before baseline visit.
- No history of treatment with Memantine or 4 weeks wash out period before baseline visit.
Duration of treatment: 6 month double-blind phase 6 month open-label phase (optional)
Total number of subjects: A total of 220 patients will be recruited to the study from approximately 20 centers in a treatment ratio of 1:1 (8 mg BID, 110 : placebo, 110). This reflects the minimum number of patients required and also allows for a drop out rate of approximately 20%. Additional subjects may be recruited based on interim analysis.
Number of study centres: Approximately 20; multinational Europe
Number of visits: Doubble-Blind Phase: 5 visits (including screening); Open-Label Phase: 3 visits
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
- Being tested
- Lornoxicam, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LornoxicamDrug
Also called Xefo, Telos
Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
PlaceboDrug
Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Lornoxicam | Experimental | Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months. Receives: Drug: Lornoxicam |
| Placebo | Placebo comparator | Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months double blind, 6 months open-label (optional)
Secondary outcomes (1)
Activities of Daily Living - ADCS-ADL; Behavioral/Psychiatric Symptoms - NPI
Measured: 6 months double-blind, 6 months open label (optional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startSep 2009
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Lack of Efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer´s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- JSW Lifesciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elisabeth Sterner, M.Sc., Study director, JSW-Life SciencesReinhold Schmidt, MD, Study chairMichael Rainer, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117948
- Sponsor's protocol ID
- CR081101/CO14950
- Status last verified
- Feb 2013
- First submitted
- 4 May 2010
- Last updated
- 6 Feb 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01117948
- Acronym / sponsor ID
- CR081101/CO14950
- Conditions
- Alzheimer´s Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Efficacy
- Enrolment
- 219 participants (actual)
- Lead sponsor
- JSW LifesciencesUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Posted 29 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study objectives: Primary:
To evaluate the efficacy of Lornoxicam (8 mg, BID) administered for 6 months versus matched placebo based on the following end-point:
- Cognitive performance - ADAS-cog+
Secondary:
To evaluate the efficacy of Lornoxicam (8 mg, BID) administered for 6 months versus matched placebo based on the following end-point:
- Activities of daily living - ADCS-ADL
- Behavioral / psychiatric symptoms - NPI
To evaluate the safety of Lornoxicam (8 mg, BID) administered for 6 months versus matched placebo.
- Overall incidence of adverse events.
Exploratory:
In a subgroup of 50 patients MRI analyses will be performed. In a subgroup of 50 patients exploratory data on the production of amyloid biological markers - blood plasma concentration of Aß1-38, Aß1-40 and Aß1-42 will be collected.
An optional 6 month open-label phase will be available.
Subject population, diagnosis and main criteria for inclusion: Male and female patients with mild to moderate probable Alzheimer's Disease according to NINCDS-ADRDA criteria
- Age 50 - 85 years inclusive
- MMSE 18-26 inclusive
- No history of treatment with Acetylcholine-esterase inhibitors or 4 weeks wash out period before baseline visit.
- No history of treatment with Memantine or 4 weeks wash out period before baseline visit.
Duration of treatment: 6 month double-blind phase 6 month open-label phase (optional)
Total number of subjects: A total of 220 patients will be recruited to the study from approximately 20 centers in a treatment ratio of 1:1 (8 mg BID, 110 : placebo, 110). This reflects the minimum number of patients required and also allows for a drop out rate of approximately 20%. Additional subjects may be recruited based on interim analysis.
Number of study centres: Approximately 20; multinational Europe
Number of visits: Doubble-Blind Phase: 5 visits (including screening); Open-Label Phase: 3 visits
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lornoxicam | Experimental | Drug: LornoxicamLornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LornoxicamAlso: Xefo, TelosLornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months. | Drug | Lornoxicam |
| PlaceboPlacebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months. | Drug | Placebo |
Primary outcome
Cognitive Performance - ADAS-cog+
Time frame: 6 months double blind, 6 months open-label (optional)
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).
1 secondary outcome
Activities of Daily Living - ADCS-ADL; Behavioral/Psychiatric Symptoms - NPI
Time frame: 6 months double-blind, 6 months open label (optional)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Sterner, M.Sc. study director
JSW-Life Sciences
Reinhold Schmidt, MD study chair
Michael Rainer, MD principal investigator
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lornoxicam in people with Alzheimer´s Disease, run by JSW Lifesciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Performance - ADAS-cog+ (time frame: 6 months double blind, 6 months open-label (optional)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013.