TerminatedPhase 2Results posted

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

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.

Lead sponsor

JSW Lifesciences

Asset

Lornoxicam

Listed sites

Recruiting sites

Enrollment

219

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 18-26

Primary endpoint

•ADAS-Cog

Identifiers

Registered as

Org study IDCR081101/CO14950

NCT IDNCT01117948

Timeline

Milestones

Study start2009-09 (month precision)

Study first posted2010-05-06estimated

Primary completion2011-04actual (month precision)

Study completion2011-04actual (month precision)

Results first posted2012-11-29estimated

Last update posted2013-02-06estimated

Assets

Drug assets

Lornoxicam

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Function / daily living

Global cognition

2 endpoints

Primary/protocol endpoint

Cognitive Performance - ADAS-cog+

Time frame:6 months double blind, 6 months open-label (optional)

ADAS-Cog

change from baseline, improvement

Primary/registry result

Cognitive Performance - ADAS-cog+

Time frame:6 months double blind, 6 months open-label (optional)

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), units on a scale	Standard deviation
Lornoxicamn=93 Participants	-0.05	6.75
Placebon=98 Participants	-0.89	7.84

Function / daily living

2 endpoints

Secondary/protocol endpoint

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

Time frame:6 months double-blind, 6 months open label (optional)

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Secondary/registry result

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

Time frame:6 months double-blind, 6 months open label (optional)

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.