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.
Conditions
Interventions
Product Name: Phenserine tartrate 5mg tablet
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Phenserine Tartrate
Current Sponsor code: Phenserine Tartrate
Other descriptive name: [(-)-Phenylca
Sponsors
Axonyx Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Males of at least 50 years of age; •Females of at least 50 years of age, who are either at least 2 years post-menopausal or surgically sterile; •Probable Alzheimer’s disease consistent with National Institute of Neurological and Communicative Diseases and Stroke / Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria; •Have had a computed tomography (CT) or magnetic resonance imaging (MRI) brain scan within the 12 months prior to inclusion in the study that is indicative of probable Alzheimer’s disease; •A Mini-Mental State Examination (MMSE) score of between 12 and 24 (inclusive) at Visit 1 (screening); •A modified Hachinsky Ischemic Scale (mHIS) score equal to or below 4 at Visit 1 (screening); •Reliable caregiver available, and if not living in the same household, caregiver sees patient at least 4 times a week or a total of 15 to 20 hours per week; •Patients who do not need continuous nursing care and who are either living at home or in an institutional setting; •General health status acceptable for participation in a 6 month clinical study; •Is capable of understanding and has given written informed consent [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; •Agrees to comply with protocol requirements. 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: General •Failure to perform or comply with screening or baseline examinations; •Hospitalisation (except for study purposes or due to social reasons, e.g. hospitalisation to unburden the caregiver); •Change of concomitant medication 4 weeks prior to screening or during screening period; •Participation in another therapeutic clinical study within the 3 months before Visit 2 (baseline); •Inability to swallow tablets. Medical •Vitamin B12 or folate deficiency unless treated in which case treatment needs to have been stable for 3 months before study entry; •Hypothyroidism, defined as any thyroid-stimulating hormone elevation. Corrected hypothyroidism is allowed provided treatment has been stable for 3 months before study entry; •Juvenile onset diabetes mellitus; •Adult onset diabetes mellitus insufficiently controlled [Haemoglobin A1c (HbA1c) > 8%]; •A malignancy within the last 5 years; •HIV infection; •Any history of hepatic insufficiency or abnormal liver enzymes; •Renal insufficiency with abnormal serum creatinine outside the age appropriate normal range; •Serum electrolytes (sodium, potassium, magnesium) outside the age appropriate normal range; •Clinically significant abnormal laboratory values outside the age appropriate normal range; •Hypersensitivity to cholinergic drugs; •Uncontrolled asthma. Cardiovascular •Myocardial infarction or unstable angina within the 6 months prior to Visit 1 (screening); •History of more than one myocardial infarction during the last 5 years; •Cardiomyopathy; •Myocarditis; •Severe hypotension; •Severe hypertension requiring treatment with more than 2 drugs; •Bradycardia (frequency of heart beat 90/minute); •Presence of AV block (type II / Mobitz II and type III); •Congenital long QT syndrome; •Sinus node dysfunction; •Prolonged QTcB-interval (males > 450 msec; females > 470 msec); •Presence of U wave. Psychiatric •Axis I diagnosis within 1 year prior to study entry; •Previous diagnosis of bipolar affective disorder or schizophrenia; •Current alcohol or substance abuse or dependence; •Metabolic or toxic encephalopathy or dementia due to a general medical condition; •Geriatric Depression Score (GDS) > 5 at Visit 1 (screening). Neurological •Stroke within the 6 months prior to Visit 1 (screening) or concomitant with onset of dementia; •Tumours, subdural haematoma or other space-occupying processes on CT/MRI; •Head trauma with loss of consciousness within 1 year of the onset of dementia; •Head trauma with loss of consciousness concurrent with the onset of dementia; •Onset of dementia within 1 year following cardiac arrest, surgery with general anaesthetic or resuscitation; •Degenerative central nervous system conditions e.g. Huntington’s disease (Huntington’s chorea), Creutzfeld-Jakob disease, Parkinson’s disease, etc.; •Genetic cognitive impairment e.g. Trisomy 21 (Down’s syndrome); •Wernicke’s encephalopathy; •Acute or chronic central nervous system infection including tertiary syphilis; •Epilepsy. Previous Medication Has previously received: •Any acetylcholinesterase inhibitor in the 3 months before study entry; •Any experimental drug 3 months before Visit 2 (baseline); •Nootropics 1 month before Visit 1 (screening); •Benzodiazepines administered on a chronic basis; •Antipsychotics (unless prescribed for sleep disturbances) in the 3 months preceding study entry. If prescribed for sleep disturbance, then these should be discontinued 2 weeks p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cognitive performance [Alzheimer's Disease Assessment Scale - Cognitive Items (ADAS-COG)]; Activities of daily living [Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)].;Secondary Objective: ADAS-COG+ [Modified Alzheimer's Disease Assessment Scale - Cognitive Items (ADAS-COG+)]; Global clinical impression of therapeutic effect [Clinician's Interview Based Impression of Change (CIBIC+)]; Behavioural / psychiatric symptoms [Neuropsychiatric Inventory (NPI)].;Primary end point(s): The following efficacy assessments will be conducted in this study: •ADAS-COG / ADAS-COG+; •ADCS-ADL; •Clinician’s Interview Based Impression (CIBI+) comprising the Clinician’s Interview Based Impression of Disease Severity (CIBIS+) or the Clinician’s Interview based Impression of Change (CIBIC+); •NPI. | — |
Countries
Hungary
Outcome results
None listed