Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease
Condition: Alzheimer's Disease; Dementia; Memory Loss; Cognitive Impairment
MeSH terms: Alzheimer Disease; Dementia; Memory Disorders; Amnesia; Cognitive Dysfunction
Intervention: ladostigil hemitartrate
Intervention description: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 200.0
Sex: All
Minimum age: 60 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; Dementia; Memory Loss; Cognitive Impairment; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Delirium, Dementia, Amnestic, Cognitive Disorders; Mental Disorders; Depression; Anxiety

Summary:

      For many, Alzheimer's disease is the number one medical issue facing our aging society. It is
      a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory and
      cognitive performance. There are no known treatments that can either prevent or reverse its
      progression. Consequently, there still remains a need to evaluate treatments which can better
      stabilize the symptoms of this disease. These symptoms frequently include decreased
      functional capacity and negative psychological attributes (e,g, depression, anxiety) in
      association with the memory and cognition deficits. This current study is being done to
      assess an investigational compound that has been designed to not only improved the cognitive
      status of affected patients but to also better manage all symptoms. Hence, the ultimate goal
      is to provide patients with an improved quality of life by slowing the progression of this
      neurodegenerative disease
    

Eligibility 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