CURRENT RECRUITING TRIALS

ALN APP (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).  

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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. 

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CELIA (MCI, Mild AD)

A Study to Assess if BIIB080 Can Change Clinical Dementia Rating-Sum of Boxes Scores, and BIIB080 Safety and Tolerability When Injected Into the Cerebrospinal Fluid of Participants With Mild Cognitive Impairment Due to Alzheimer’s Disease (AD) or Mild AD Dementia Between 50 to 80 Years of Age (CELIA)

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.

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ENVISION (Early AD)

A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer’s Disease (ENVISION)

The primary objective of this study is to verify the clinical benefit of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score as compared with placebo in participants with early Alzheimer’s disease.

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FOCUS C9 (WVE-04)

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 1b/2a Study of WVE-004 Administered Intrathecally to Patients with C9orf72-associated Amyotrophic Lateral Sclerosis (ALS) or Frontotemporal Dementia (FTD)

This is a clinical trial of WVE-004, a new drug under development for individuals with either ALS or FTD associated with an expansion in the C9orf72 gene. Clinical trials gather evidence about the safety and effectiveness of new drugs. Right now, WVE-004 can only be used in clinical trials, because it has not been proven safe or effective enough to be used in regular medical practice.

This study is what we call a “first-in-human” study. In a first-in-human study, the intervention has never been tested on humans before. This study is allowed to be conducted because the information that has been obtained through conducting tests in laboratories and animals suggests that the intervention could be safe for humans. However, there is no proof yet that it is safe for humans to receive this intervention. A “first-in-human” study aims at proving that humans can be exposed to the intervention without suffering from side effects that are too severe; a first-in-human study does not aim at demonstrating effectiveness of the intervention.

The purpose of this study is to determine if WVE-004 is safe and well tolerated in patients with ALS or FTD when compared with a placebo control.

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.

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INHANCE

Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise

Researchers from McGill University will ask you to complete a computerized brain training program at home for 30 mins a day for 10 weeks. You will also be asked to visit our office in Montreal, Quebec to receive a complete overview of the study, cognitive assessments and brain imaging (PET, MRI) before and after your training program. You can be reimbursed up to $211 CAD for your participation.

Who do we need?

  1. Participants who are 65 or older without dementia
  2. Speak fluent French or English
  3. Can access the internet
  4. Can receive MRI and PET scans
  5. Can use a brain training program on a study provided tablet
ION717 (Creutzfeldt-Jakob, Prion)

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ION717

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intrathecal (IT) delivery of ION717.

Passage Bio upliFT-D (FTD)

A Study of PBFT02 in Patients With Frontotemporal Dementia and Progranulin Mutations (FTD-GRN) (upliFT-D)

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).

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CONTACT US

For information on our trials,  contact us at neurocog-cru.neuro@mcgill.ca.

ABOUT OUR STUDIES

PASSAGE BIO: FTD

INHANCE: Cognitive Training

AUTONOMY: Early Alzheimer

UPCOMING TRIALS

To come

THE TEAM

Dr Simon Ducharme

Dr Simon Ducharme

Principal Investigator

The team

Dr. Etienne de Villers-Sidani

Dr. Etienne de Villers-Sidani

Principal Investigator

ACTIVE (NOT RECRUITING) TRIALS

COMPASS (CCNA)

THE COMPREHENSIVE ASSESSMENT OF NEURODEGENERATION DEMENTIA (COMPASS-ND) STUDY

You (the research participant) are being asked to participate in a research study designed to assess individuals with different sorts of cognitive and movement changes seen in older adults. We (the study sponsor) will look at the usefulness of imaging studies, clinical assessments and biomarker tests (blood, saliva, urine, cerebrospinal fluid (optional), and feces (optional)) together with measurements of memory, thinking and daily functioning, for distinguishing these changes from each other and from healthy aging. You have been asked to participate because there are concerns about your memory, thinking or speaking ability, your behaviour, abnormal movements or problems walking, or because you have none of these concerns or problems and can be part of a healthy aging comparison group.

EMBARK
Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects with Alzheimer’s Disease who had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

This is a clinical trial of aducanumab, a drug under development for Alzheimer’s disease. Clinical trials gather evidence about the safety and effectiveness of new drugs. Right now, aducanumab can only be used in clinical trials, because it has not been proven safe or effective enough to be used in regular medical practice. However, it has already been tested in humans to see how safe it is and whether it works. Health Canada does not object to its use in clinical trials.

The purpose of this study is to evaluate the safety and tolerability of high dose aducanumab for a longer period.

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Romina Perrotti

Romina Perrotti

Team Lead, Sr. Research Coordinator

Luciano Buonamici

Luciano Buonamici

Clinical Research Coordinator

Niloofar Barzegar

Niloofar Barzegar

Clinical Research Coordinator