Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01354691
• Date of registration: 01/05/2011
• Primary sponsor: Avraham Pharmaceuticals Ltd
• Public title: Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease
• Scientific title: A 6-Month Prospective, Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Adaptive-Trial-Design Study to Evaluate the Safety and Efficacy of 80mg b.i.d Ladostigil in Patients With Mild to Moderate Probable Alzheimer's Disease With a 6-Month Open Label Follow-Up Period
• Date of first enrolment: February 2011
• Target sample size: 188
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01354691
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Austria, Croatia, Germany, Serbia, Spain

Contacts

• Name: Reinhold Schmidt, MD
• Affiliation: Medizinische Universitat Graz

Key inclusion & exclusion criteria

Inclusion Criteria:

- AD diagnosis according to NINCDS-ADRDA criteria

- Mild to moderate AD according to MMSE 14-24 inclusive

- MRI or CT assessment within 6 months before baseline, corroborating the clinical
diagnosis and excluding other potential causes of dementia especially cerebrovascular
lesions

- Absence of major depressive disease according to CSDD of less than or equal to 18

- Modified Hachinski Ischemic Scale equal to or below 4

- Education for eight or more years

- Previous decline in cognition for more than six months as documented in patient
medical records

- A caregiver available and living in the same household or interacting with the
patient daily and available if necessary to assure administration of investigational
product

- Patients living at home or nursing home setting without continuous nursing care

- General health status acceptable for participation in a 12-month clinical trial and
ability to swallow oral medication

- No history of treatment with rivastigmine

- For patients with either donepezil or galantamine anti-cholinesterase inhibitor
treatment prescribed, stopped treatment four weeks prior to screening

- For patients with memantine treatment prescribed, stopped treatment four weeks prior
to screening

Exclusion Criteria:

- Other primary degenerative dementias (e.g. dementia with Lewy bodies, fronto-temporal
dementia, Huntington's disease, Jacob-Creutzfeldt disease)

- Other neurodegenerative conditions (Parkinson's disease. amyotrophic lateral
sclerosis, etc)

- Other central nervous system diseases (severe head trauma, tumors, subdural hematoma,
etc)

- A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar
disorder

- Seizure disorders

- Other infectious, metabolic or systemic diseases affecting central nervous system
(syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, serum
electrolytes out of normal range, juvenile onset diabetes mellitus, etc)

- Clinically significant, advanced or unstable disease that may interfere with primary
or secondary variable evaluations

- Other unstable, chronic or clinically significant medical conditions involving major
organs like kidney, liver, lungs and heart/vasculature

- Hospitalization or change of chronic concomitant medications one month prior to
screening or during screening period



Age minimum: 60 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Alzheimer's Disease

Cognitive Impairment

Dementia

Memory Loss

Intervention(s)

Drug: ladostigil hemitartrate

Primary Outcome(s)

ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale [Time Frame: 26 weeks]

Safety Evaluation [Time Frame: 6,15 26, 39 and 52 week assessment of safety and tolerability]

Secondary Outcome(s)

ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive Subscale [Time Frame: 6, 15, 39 and 52 weeks]

Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [Time Frame: 6, 15, 26, 39 and 52 weeks]

Cornell Scale for Depression in Dementia (CSDD) [Time Frame: 6, 15, 26, 39 and 52 weeks]

Mini-Mental State Examination (MMSE) [Time Frame: 6, 15, 26, 39 and 52 weeks]

Neuropsychiatric Inventory (NPI) [Time Frame: 6, 15, 26, 39 and 52 weeks]

Secondary ID(s)

CR100101/CO15570

Source(s) of Monetary Support

Please refer to primary and secondary sponsors