CURRENT RECRUITING TRIALS
CONTACT US
(514) 398-5500 or neurocog-cru.neuro@mcgill.ca
IONIS ION717 (Prion Disease)
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717 in Patients with Prion Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intrathecal (IT) delivery of ION717.
This is a first-in-human, randomized, multi-center study in participants with prion disease. Eligible participants will receive ION717 and placebo. The study will consist of a screening period of up to 6 weeks, a 30-week double-blind treatment period, a 70-week open-label extension period and a 32-week post-treatment period. During the double-blind period, the order of ION717 and placebo doses will be randomized and blinded to participants, study sites and the Sponsor. During the open-label extension period, all participants will receive ION717. Multiple dose levels will be tested.
GENFI (FTD)
Genetic Frontotemporal Dementia Initiative 2
From genfi.org.:
The aim of the study is to understand more about genetic FTD, particularly in those who have mutations in the progranulin (GRN), microtubule-associated protein tau (MAPT) and chromosome 9 open reading frame 72 (C9ORF72) genes. There are now promising avenues for treatment of these disorders but we still do not know when drugs should be started or how we should measure the response to treatment.
GENFI investigates both people who have developed symptoms and also people who have a risk of developing symptoms in the future because they carry an abnormal genetic mutation. By studying these individuals who are destined to develop the disease later in life we can understand the development from the very earliest changes. The key objectives of GENFI are therefore to develop markers which help identify the disease at its earliest stage as well as markers that allow the progression of the disease to be tracked.
The eventual aim will be to use these markers in future clinical trials of drugs in genetic FTD.
PASSAGE BIO upliFT-D (FTD)
PBFT02 is a gene therapy for frontotemporal dementia intended to deliver a functional copy of the GRN gene to the brain.
This study will assess the safety, tolerability and efficacy of this treatment in patients with frontotemporal dementia and mutations in the progranulin gene (FTD-GRN).
UPCOMING TRIALS
Arrowhead ARO-MAPT-SC 1001 (Early Alzheimer's Disease)
Study of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer’s Disease
Posit Science INHANCE-MCI (Mild Cognitive Impairment)
A neuroplasticity-based, computerized cognitive training programs to improve neurological and neuropsychological health in older adults with mild cognitive impairment (MCI).
The primary objective of this study is to evaluate will evaluate the impact of speed training to change cholinergic signaling, cognitive performance, and functional abilities in patients with MCI, as evidenced by [18F]fluoroethoxybenzovesamicol (FEOBV) positron-emission tomography (PET) and standard measures of cognition and function.
The investigators will employ a prospective, double-blind, parallel-arm, active-controlled, randomized clinical trial in patients with clinically-defined mild cognitive impairment aged 65 and above with a baseline MoCA of 18-26 inclusive.
Roche BP45770 (early AD)
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzherimer’s Disease (eAD)
This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD. It is a  Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 Following Intrathecal Administration in Participants With Early Symptomatic Alzheimer’s Disease.Â
Roche MEADOW (early AD)
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 Following Intrathecal Administration in Participants With Early Symptomatic Alzheimer’s Disease.Â
This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.
ACTIVE (NOT RECRUITING) TRIALS
ALN APP-001 (Early AD)
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
The purpose of this study is to evaluate the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of single intrathecal (IT) doses of ALN-APP in adult patients with early-onset Alzheimer’s Disease (EOAD). Â
AUTONOMY (Early AD)
A Study of JNJ-63733657 in Participants With Early Alzheimer’s Disease (Autonomy)
Alzheimer’s disease (AD) is a fatal neurodegenerative disease that is manifested by progressive cognitive deficits including memory loss followed by loss of independent function as well as neuropsychiatric symptoms such as apathy, depression, anxiety, agitation and psychosis. JNJ-63733657 is a humanized monoclonal anti-tau antibody which binds to phosphorylated tau (P-tau).
The study will evaluate whether JNJ-63733657 can slow clinical (cognitive and functional) decline in participants with Early AD with evidence of elevated brain tau (T+) and assess its safety and tolerability.Â
CELIA (MCI)
In this study, researchers will learn more about a study drug called BIIB080. The study will focus on participants with mild cognitive impairment or mild dementia due to AD.
The main question researchers are trying to answer is if BIIB080 can slow the worsening of AD more than placebo. It will focus on what dose of BIIB080 slows worsening of AD the most.
To help answer this question, researchers will use the Clinical Dementia Rating-Sum of Boxes, also known as the CDR-SB.
- Clinicians use the CDR-SB to measure several categories of dementia symptoms.
- The results for each category are added together for a total score. Lower scores are better.
Researchers will also learn more about the safety of BIIB080.
Washington U - DIAN-TU-001
As part of the DIAN-TU-001 protocol, participants undergo longitudinal assessments that include clinical assessment, cognitive testing, magnetic resonance imaging (MRI) and amyloid and tau positron emission tomography (PET) imaging, and analysis of blood and cerebrospinal fluid (CSF).
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THE TEAM
Dr Simon Ducharme
Principal Investigator
Elisabeth Sylvain
Team Lead
Nadine Zablith
Clinical Research Coordinator
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Dr de Villers-Sidani
Principal Investigator
Yara Nasr
Research Coord.
Celia Sciandra
Clinical Research Coordinator