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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avraham Pharmaceuticals Ltd
ClinicalTrials.gov Identifier:
NCT01354691
First received: May 1, 2011
Last updated: July 22, 2013
Last verified: July 2013

May 1, 2011
July 22, 2013
February 2011
September 2012   (final data collection date for primary outcome measure)
  • ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    11 item, unmodified ADAS-Cog (total possible score of 70)
  • Safety Evaluation [ Time Frame: 6,15 26, 39 and 52 week assessment of safety and tolerability ] [ Designated as safety issue: Yes ]
    Number and severity of adverse events across trial period.
Same as current
Complete list of historical versions of study NCT01354691 on ClinicalTrials.gov Archive Site
  • Neuropsychiatric Inventory (NPI) [ Time Frame: 6, 15, 26, 39 and 52 weeks ] [ Designated as safety issue: No ]
    Assessment of behavioral and psychological symptoms of disease
  • Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: 6, 15, 26, 39 and 52 weeks ] [ Designated as safety issue: No ]
    Assessment of depressive status
  • Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 6, 15, 26, 39 and 52 weeks ] [ Designated as safety issue: No ]
    Assessment of functional activity status
  • Mini-Mental State Examination (MMSE) [ Time Frame: 6, 15, 26, 39 and 52 weeks ] [ Designated as safety issue: No ]
    Secondary assessment of cognitive status utilizing common metric
  • ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: 6, 15, 39 and 52 weeks ] [ Designated as safety issue: No ]
    11 item, unmodified ADAS-Cog (total possible score of 70)
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease
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

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

This is a phase II, proof of concept study to evaluate the safety and efficacy of the investigational compound ladostigil versus placebo in mild to moderate Alzheimer's disease patients. The randomized, double-blind, placebo-controlled phase of the trial will be 26 weeks in duration and will involve two cohorts (i.e. one arm receiving ladostigil and one arm receiving placebo). After the initial 26 week period, all participating subjects will receive 26 weeks of treatment with ladostigil (i.e. the open label phase). A total of five territories will be participating in this trial. These include Austria, Croatia, Germany, Serbia and Spain.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Alzheimer's Disease
  • Dementia
  • Memory Loss
  • Cognitive Impairment
Drug: ladostigil hemitartrate
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.
Experimental: ladostigil hemitartrate
Intervention: Drug: ladostigil hemitartrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
March 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
60 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Croatia,   Germany,   Serbia,   Spain
 
NCT01354691
CR100101/CO15570
Yes
Avraham Pharmaceuticals Ltd
Avraham Pharmaceuticals Ltd
Not Provided
Principal Investigator: Reinhold Schmidt, MD Medizinische Universitat Graz
Avraham Pharmaceuticals Ltd
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP