A 36-month, Multi-centre, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Low Dose Ladostigil in Patients With Mild Cognitive Impairment (MCI)

NCT01429623 Phase 2 COMPLETED Results posted

The purpose of this study is to determine whether treatment with the investigational drug ladostigil will delay the onset of Alzheimer's disease(AD) in patients with Mild Cognitive Impairment (MCI). MCI is now recognized as a precursor to AD and clinical tools are available to assess cognitive performance at this earlier stage. Ladostigil is currently under investigation for the treatment of AD. In this study, the investigators will be examining ladostigil at a lower dose level. At this dose level, ladostigil has been shown to reduce signs of early memory loss in animals. Thus, in this study the investigators are attempting to determine if earlier invention with a lower dose of ladostigil will significantly reduce initial memory loss and delay the subsequent progression to more serious cognitive dysfunction.

Details

Lead sponsor	Avraham Pharmaceuticals Ltd
Phase	Phase 2
Status	COMPLETED
Enrolment	210
Start date	2012-02
Completion	2016-09

Conditions

• Mild Cognitive Impairment
• Dementia

Interventions

• ladostigil hemitartrate
• Placebo

Primary outcomes

• Conversion From Mild Cognitive Impairment to Alzheimer's Disease Compared to Placebo — 3,6,12,18,24,30 and 36 months
  Total number of conversions from Mild Cognitive Impairment to Alzheimer's disease across entire 3 year study period. Conversion is determined, or defined, by a Clinical Dementia Rating (CDR) score of greater than or equal to one. Composite rating ranges from 0 no symptoms of dementia to 3 Severe symptoms of dementia.

Countries

Austria, Germany, Israel