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The goal of this clinical trial is to test SNK01 in participants with moderate Alzheimer's Disease. The main questions it aims to answer are:
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Inclusion criteria
The participant or their legally authorized representative must be willing and able to give their informed consent in writing and comply with the requirements of this study protocol. Informed consent for participants or their legally authorized representative and caregivers will be obtained before any trial-related activity. (Trial-related activities are any procedure that would not be performed during normal treatment of the participant).
Participants must have a reliable study partner/caregiver (per investigator judgement for instance a family member, partner etc., guardian (must be always the same person)) who is in close contact with the patient, available on call and who is able to contribute to the assessment of the ratings of the functional endpoints at specific study visits. This person will be able to communicate in the language in which the participant is being assessed and should also serve as a backup contact for the study site. The study partner/caregiver must sign a separate informed consent form which describes their contributions during the study.
Patients with diagnosis of Alzheimer's dementia according to the recommendations from the 2011 National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease.
Age 40 to 85 years old.
Patients must have at least 6 years of formal education and fluency in the test language as verbally confirmed by the patient or their legally authorized representative and documented by the study investigator.
Female participants of childbearing potential must have a negative urine pregnancy test at Screening and Visit 1 before first administration of the study drug. Females of childbearing potential are defined as those who are not surgically sterile or who are not post-menopausal (i.e.: no menses for at least 1 year). Male and female participants of reproductive potential must also agree to abstinence or use acceptable form(s) of effective contraception during the study and for 30 days after the final dose of the study drug. Acceptable methods of contraception include the following:
Positive evidence for a diagnosis of AD via amyloid positron emission tomography (Amyloid PET) of the brain within the past six months.
CDR-SB score of ≥ 9.5 and <16.0.
Exclusion criteria
Primary purpose
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36 participants in 2 patient groups, including a placebo group
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Study Director
Data sourced from clinicaltrials.gov
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