Status:
COMPLETED
A Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Individuals With Alzheimer's Disease With or Without Coexisting Cerebrovascular Disease
Lead Sponsor:
Regenera Pharma Ltd
Conditions:
Mild to Moderate Dementia Due to Alzheimer's Disease
With or Without Coexisting Cerebrovascular Disease
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
This study is a randomized, double-blind, placebo-controlled, multicentre, Phase 2 study, with an optional open-label extension, to evaluate the safety, tolerability, and efficacy of RPh201 in subject...
Eligibility Criteria
Inclusion
- Subjects must be ≥65 years of age at the time of consent.
- Subjects 65-69 years old, inclusive, must have evidence of cerebrovascular disease.
- Meet National Institute on Aging-Alzheimer's Association 2011 criteria for All-Cause Dementia and have evidence for probable AD or possible AD with coexisting cerebrovascular disease. Coexisting cerebrovascular disease includes evidence of any of the following: cortical infarcts, subcortical and lacunar infarcts, macro or micro-hemorrhage, and small vessel ischemic microangiopathy.
- Willing and able to provide informed consent or, if incapable of informed consent, have a legally authorized representative willing to consent on their behalf.
- MMSE at screen visit: 15-22, inclusive.
- Cholinesterase inhibitors, memantine, and other background medications impacting cognition and mood, if used, are at stable doses for at least 6 weeks prior to screening.
- A study partner is available who has adequate contact with the subject to administer study drug, oversee study drug compliance, report on adverse events (AEs), and provide meaningful input into scales and assessments.
- Adequate hearing, vision, and fluency in the language of testing.
- Magnetic resonance imaging (MRI) of the brain must reveal findings consistent with AD with or without coexisting cerebrovascular disease. In subjects for whom brain MRI is contraindicated (e.g., presence of a pacemaker), computed tomography (CT) of the brain is acceptable. Historic MRI or CT scans up to 18 months prior to screening may be used for inclusion unless there have been interval clinical events warranting an updated scan.
- Male subjects who are sexually active must agree to use one of the following acceptable methods of birth control from Screening and for at least one month after the last dose of study drug: abstinence (no sexual intercourse), male condom, or vasectomy.
- Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Optional FDG-PET sub-study: no contraindications to PET imaging. Individuals participating in the FDG-PET sub-study will be capped at 15 volunteers and a further cap may be imposed on the number enrolling in this sub-study without evidence of cerebrovascular disease.
Exclusion
- Neurological or non-neurological conditions other than AD and cerebrovascular disease that, in the Investigator's opinion, contribute to, or provide alternative etiology for, the subject's dementia. Examples include, but are not limited to, brain tumors, clinically significant head injury, Parkinson's disease, current or prior excess use of alcohol that, in the investigator's judgment, has caused or significantly contributed to the subject's cognitive decline, or primary psychiatric disorders (e.g., schizophrenia or bipolar affective disorder).
- Unstable medical conditions which are likely to impact subject's ability to complete the trial and which are likely to confound AE assessment. These include, but are not limited to, uncontrolled hypertension, uncontrolled diabetes, and cancer within past the 2 years. Exceptions include prostate cancer in-situ and local basal and squamous cell skin cancers.
- Chronic use of systemic or inhaled steroids (use of topical steroids is acceptable).
- Other concomitant medications that, in the Investigator's judgment, impair cognition and/or confound efficacy assessments.
- Women of child-bearing potential are excluded (e.g., women who have not been post-menopausal for at least 2 years or are not surgically sterile).
- Treatment with investigational product from a previous clinical drug trial within the last 30 days or five half-lives prior to Visit 2 (Baseline), whichever is longer.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2020
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT03462121
Start Date
March 1 2018
End Date
March 30 2020
Last Update
April 30 2020
Active Locations (5)
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1
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, Canada, K9H 2P4
2
Toronto Memory Program
Toronto, Ontario, Canada, M3B 2S7
3
Gerontion Research Inc., The Center for Memory & Aging
Toronto, Ontario, Canada, M4G 3E8
4
Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Memoire de l'Outaouais
Gatineau, Quebec, Canada, J8T 8J1