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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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 Mod

Brief 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

Detailed Summary: 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.
Sponsor: Avraham Pharmaceuticals Ltd

Current Primary Outcome:

  • ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale [ Time Frame: 26 weeks ]
    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 ]
    Number and severity of adverse events across trial period.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Neuropsychiatric Inventory (NPI) [ Time Frame: 6, 15, 26, 39 and 52 weeks ]
    Assessment of behavioral and psychological symptoms of disease
  • Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: 6, 15, 26, 39 and 52 weeks ]
    Assessment of depressive status
  • Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 6, 15, 26, 39 and 52 weeks ]
    Assessment of functional activity status
  • Mini-Mental State Examination (MMSE) [ Time Frame: 6, 15, 26, 39 and 52 weeks ]
    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 ]
    11 item, unmodified ADAS-Cog (total possible score of 70)


Original Secondary Outcome: Same as current

Information By: Avraham Pharmaceuticals Ltd

Dates:
Date Received: May 1, 2011
Date Started: February 2011
Date Completion:
Last Updated: July 22, 2013
Last Verified: July 2013