Alzheimer's Disease (AD) is an irreversible, progressive neurodegenerative disorder, characterized by gradual cognitive decline, abnormal behaviour, and personality changes. MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease
Conditions
Interventions
Product Name: Alzhemed™
Product Code: NC-758
Pharmaceutical Form: Tablet
INN or Proposed INN: Tramiprosate
CAS Number: 3687-18-1
Current Sponsor code: NC-758
Concentration unit: mg milligram(s)
Concen
Sponsors
Neurochem Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The patient must have completed the 78-week treatment period of the double-blind CL-758010 study. 2) Female patients must be of non-childbearing potential (i.e. surgically sterilized or at least two years post-menopausal). 3) Male subjects who are sexually active must: a. Be proven to be sterile e.g. vasectomy or; b. Use appropriate contraceptive barrier methods, e.g. a condom. For the latter, in the event where the participant cannot reliably use/or is unable to use contraceptive barriers, his partner (if of childbearing potential) should be instructed to use appropriate contraceptive devices or methods to avoid pregnancy. 4) The patient must be living in a community with a reliable caregiver that will be attending each clinic visit, completing required evaluations, supervising and ensuring the administration of all doses of medication during the entire study. A reliable caregiver is an individual who has daily contacts with the patient (e.g. visits and/or phone calls). For consistency, it is recommended to have the same caregiver accompanying the patient at each visit. Patients living in assisted living facilities may be included in the study as long as the study medication intake is supervised and that the patient has a reliable caregiver. Due to the length of this study, it is highly recommended to identify other potential caregivers during the screening evaluation. 5) There must be signed informed consent from the patient or legal representative and the caregiver. 6) The potential participant must be able to perform the required psychometric tests and evaluations. Visual and auditory acuity (with glasses or hearing aid, if required) must be sufficient to complete the protocol-specified measures. 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: 1) The patient has acquired immune deficiency syndrome (AIDS) or is positive for the human immunodeficiency virus (HIV), as revealed through medical history. 2) The patient has an allergy and/or hypersensitivity to any component of the study medication. 3) The patient has a history of drug or alcohol abuse within the previous five years. 4) The patient has a clinically significant and/or uncontrolled medical condition that, in the opinion of the treating physician, would pose a safety risk if the patient continued taking the study medication. 5) The presence of a significant nutritional deficiency, as defined by a Mini Nutritional Assessment (MNA) score of less than 17. 6) The patient has a clinical condition that might interfere with the interpretation of safety results. 7) The patient has a condition that can significantly affect the absorption of the study medication. 8) The patient participates in another trial during the study. 9) The patient is unable to swallow medication tablets. 10) The patient is otherwise unsuitable for this type of trial as determined by the treating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this open-label study is to evaluate the long-term safety of Alzhemed™ in patients with Alzheimer’s Disease (AD).;Secondary Objective: • Assess the long-term effect of Alzhemed™ on global cognitive functioning using the AD Assessment Scale, cognitive subscale (ADAS-cog) and the Mini Mental State Examination (MMSE) scale. • Assess the long-term effect of Alzhemed™ on global clinical status using the Clinical Dementia Rating Sum of Boxes (CDR-SB). • Assess the effect of a delay in the initiation of Alzhemed™ treatment on global cognitive functioning using the ADAS-cog and MMSE scales. • Assess the effect of a delay in initiation of Alzhemed™ treatment on global clinical status using the CDR-SB. • Assess the long-term effect of Alzhemed™ treatment on patterns of health care resource utilization using the RUD Lite© instrument. • Assess the effect of a delay in initiation of Alzhemed™ treatment on patterns of health care resource utilization using the RUD Lite© instrument. • Assess changes in cognitive functioning and clinical status according to disease severity. ;Primary end point(s): Safety Measures • Adverse event assessments • Clinical laboratory parameters • Vital signs/physical examinations/electrocardiograms | — |
Countries
Belgium, France, Sweden, United Kingdom
Outcome results
None listed