A Phase 3 Double-blind, Randomized, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of AR1001 over 52 Weeks in Participants with Early Alzheimer’s Disease: POLARIS -AD study
Summary
This is a new drug AR1001 30mg QD versus placebo taken by mouth. The main therapeutic effects of AR1001 confirmed in non-clinical studies are summarized as follows: 1) inhibition of neuron apoptosis, 2) promotion of neurogenesis, 3) restoration of synaptic plasticity and 4) removal of misfolded and aggregated toxic proteins.
This is a phase 3 double-blind, randomized (the flip of a coin), placebo-controlled, multicenter, parallel group comparison trial to evaluate the efficacy and safety of AR1001 over 52 weeks of treatment in participants with early AD.
By chance (like the flip of a coin) participants will be given the study drug or a fake drug. This study is being done in many cities to see if the study drug does improve a person's memory and is safe to take. Participant's need to have been diagnosed with early Alzheimer's Disease and the study will be conducted over 1 year. There is a opportunity to continued in an extended phase of the study.
The trial consists of four phases of the following durations:
• Screening phase (6 weeks; Week -6 to Week 0) • Treatment phase (52 weeks; Week 0 to Week 52) • Optional extension phase (52 weeks; Week 52 to Week 104) • Safety Follow-up phase (4 weeks; Week 104 to Week 108)
Eligibility
Eligible ages: 55 to 90
Inclusion criteria:
Inclusion Criteria (can possibly participate)
1. Male or female participants aged 55 to 90 years of age at the time of signing the
informed consent form
2. Mild cognitive impairment or mild dementia consistent with Alzheimer's Disease. Confirmed by a PET scan or by lumbar puncture (spinal tap) and taking fluid from this procedure (cerebral spinal fluid ) for biomarker confirmation.
3. Participants with a history of subjective cognitive (they think they have memory problems and memory decline) with onset within 5 years before Screening, confirmed by study partner.
4. Participants who have a cognitive test (MMSE score) greater than or equal to 20
5. Participants and caregiver(s) who can sign an informed consent to participate in the study
6. Participants who have one (or more) identified adult study partner(s) who, in the opinion of the Investigator, has sufficient contact with and knowledge about the participant as to be able to report knowledgeably about the participant’s cognition, function, behaviour, and safety, and compliance with the protocol
More inclusions will be at screening visit.
Exclusion criteria:
Exclusions (can not participate):
1. Participants who are female and are either pregnant, nursing, or of childbearing potential
2. Participants who have signs of significant delirium (confusion), significant head trauma, alcohol abuse, frontotemporal dementia, Huntington Disease, Parkinsonism (e.g., Parkinson’s disease, Dementia with Lewy Bodies, etc.), significant cerebrovascular disease and/or significant seizure disorder, history of vascular dementia
3. Participants with a history of heart disease such as: myocardial infarction (heart attack), unstable angina (chest/heart pain), coronary artery disease, uncontrolled high blood pressure, history of HIV, liver disease
4. Cancer, with the exception of:
a. Basal or squamous cell carcinoma which has been treated
b. Grade 1 cervical cancer, fully treated for at least 2 years prior to screening, and without
returning
c. Prostate cancer, confined to the prostate gland, which has been treated
5. Not adequate treatment for thyroid disease.
6. Alcohol or substance use disorder within the past 5 years
7. Participants taking an oral (memory medication) but not on a stable dose for at least 3 months prior to screening
Other exclusions will be discussed at screening
Participate
Fill out the following form if you want to participate in this research
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Additional information
Contact information
Dr. Eric Smith, Primary Investigator 403-944-1594, Karyn Fischer Research RN 403-220-8394
Principal investigator:
Eric Smith
Clinical trial:
Yes
REB-ID:
REB24-1616