Clinical trial: The Ontario Neurodegenerative Disease Research Initiative (NCT04104373)

Eligibility criteria:
Inclusion Criteria:

          -  Written informed consent must be obtained and documented.

          -  Participant must rate his/her level of proficiency in speaking and understanding
             English at 7 out of 10 or higher on the two LEAP-Q questions.

          -  Participant must have ≥ 8 years education.

          -  Participant with a minimum MoCA score of ≥18.

               -  Exception: FTD minimum MoCA score of ≥ 14.

          -  Participant must have a reliable Study Partner. The Study Partner must:

               -  Interact regularly with the participant (i.e., have contact with the participant
                  at least once a month over the phone, email, or face-to-face);

               -  Know the participant well enough to answer questions about the her/his cognitive
                  abilities, communication skills, mood, and daily functioning (i.e., known the
                  participant for at least 2 years);

               -  Provide written informed consent and complete study questionnaires;

               -  Be willing and able to assist in compliance with study procedures (if required).

          -  Geographic accessibility to the study site.

          -  Participant must be able to walk (assistive aids may be used, e.g., cane, walker,
             etc.).

        Exclusion Criteria:

          -  Serious underlying disease other than the disease being studied which in the opinion
             of the investigator may interfere with the participant's ability to participate fully
             in the study.

          -  Any disease that would/could lead to death over the next 3 to 5 years (i.e.,
             cardiac/renal/liver cancer) with poor prognosis.

          -  Participant has been diagnosed with more than one of the five diseases (AD/MCI, ALS,
             FTD, PD or VCI) being studied.

          -  History of alcohol or drug abuse, which in the opinion of the investigator, may
             interfere with the participant's ability to comply with the study procedures.

          -  Presence of any of the following clinical conditions:

               -  Substance abuse within the past year.

               -  Unstable cardiac, pulmonary, renal, hepatic, endocrine, hematologic, or active
                  malignancy or infectious disease.

               -  AIDS or AIDS-related complex.

               -  Unstable psychiatric illness defined as psychosis (hallucinations or delusions)
                  or untreated major depression within 90 days of the screening visit.

          -  Participant is currently enrolled in a disease modifying therapeutic (drug or
             interventional) trial or observational study that the Executive Committee feels would
             compromise study results.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? 0