Alzheimer's disease is caused by a loss of nerve cells in the brain, particularly in the areas associated with memory and learning. The onset of Alzheimer's also affects the levels of a certain neurotransmitter in the brain. MedDRA version: 4.1 Level: HLT Classification code 10001897
Conditions
Interventions
Product Name: Phenserine tartrate 5 mg tablet
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Phenserine tartrate
Current Sponsor code: Phenserine tartrate
Other descriptive name: [(-)-Phenylc
Sponsors
Axonyx Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: After successfully completing the AX-CL-09 study, patients will be enrolled in the extension study and will continue to receive study medication without a break (i.e. rollover directly into the extension study). In order to be eligible for inclusion in this extension study, patients must have successfully completed the AX-CL-09 study and continue to fulfil the inclusion criteria for the AX-CL-09 study. In addition, patients must fulfil the following: • General health status acceptable for participation in a 6 month extension study; • Are capable of understanding and have given written informed consent for the extension study [or this has been provided by their acceptable representative (according to local requirements)] and a separate caregiver responsibilities and consent form has also been signed by the patient’s caregiver; • Have a reliable caregiver available, and if not living in the same household, the caregiver sees the patient at least 4 times a week or a total of 15 to 20 hours per week; • Agrees to comply with the protocol requirements of the extension study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who complete the AX-CL-09 study may have received the investigational drug phenserine-tartrate, which is an acetylcholinesterase inhibitor. These patients are eligible for enrolment in the AX-CL-09e extension study providing they have not received any other acetylcholinesterase inhibitor in the 3 months before study entry, and providing they do not fulfil any other exclusion criteria from the AX CL-09 study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this extension study is to examine the long term effect of treatment with phenserine-tartrate and possibly evaluate the disease modifying potential of phenserine-tartrate.;Secondary Objective: To investigate the long term safety profile of phenserine-tartrate.;Primary end point(s): The long term efficacy profile will be assessed using the following endpoints Primary: • Cognitive performance using ADAS-COG. | — |
Countries
United Kingdom
Outcome results
None listed