Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease

Launched by ACTINOGEN MEDICAL · Nov 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Xanamem, which is being tested as a treatment for people with mild to moderate dementia caused by Alzheimer's Disease. The goal is to see if Xanamem is safe, tolerable, and effective in helping with the symptoms of this condition. Participants in the trial will either receive 10 mg of Xanamem once a day or a placebo (a substance that looks like the medication but has no active ingredients) for 36 weeks. This trial is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo.

To be eligible for this trial, participants need to be at least 50 years old and have a diagnosis of mild or moderate dementia, confirmed by specific tests that assess memory and thinking skills. They should also have a partner who can attend visits and provide feedback about their condition. Participants must be willing to commit to the trial for up to 9 months and attend several appointments. It's important to note that certain medical conditions and recent treatments could disqualify someone from participating. If you or a loved one are interested, this trial offers a chance to contribute to research that may improve treatments for Alzheimer's Disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female aged 50 years or older, inclusive at the time of Screening.
• * Clinical syndrome of mild or moderate dementia, likely to be due to AD in the opinion of the Investigator, at Screening, including meeting the following criteria:
• • 1. Clinical Dementia Rating (CDR) global score of 0.5 to 1.0
• • 2. Mini-mental state examination (MMSE) score of 18 to 26
• • 3. Magnetic resonance imaging (MRI) or computerized tomography (CT) scan within 1 year prior to randomization that excludes alternative diagnoses for dementia such as large stroke, likely vascular dementia, brain tumor, subdural hematoma, or other non-AD dementia type findings
• • 4. Positive plasma AD biomarker signature at Pre-screening, comprising fasting levels of a tau species protein.
• • If receiving symptomatic AD medications, the dosing regimen must have been stable for 3 months prior to Screening.
• • Has a consenting trial partner who, in the Investigator's judgment, has frequent and sufficient contact with the participant to be able to provide accurate information as to the participant's cognitive and functional abilities. The trial partner must be available to provide information to the Investigator and trial site staff about the participant and agrees to attend all trial site visits in person for scale completion. A trial partner should be available for the duration of the trial. The measure of adequate availability will be at the Investigator's discretion.
• • Participants must be able to comfortably abstain from caffeine intake for 4 hours prior to scheduled cognitive assessments.
• • Smokers are eligible if they are able to comfortably abstain from nicotine / tobacco products for 2 hours prior to scheduled cognitive assessments.
• • Must provide written informed consent to participate in the trial and be willing and able to participate for the maximum of 9 months of treatment and up to 11.5 months of site visits.
• Exclusion Criteria:
• • Use of anti-amyloid or anti-tau antibody within 6 months.
• • Diagnosis of a non-AD dementia including traumatic brain injury.
• • Diagnosis of an active major mental illness of concern in the opinion in the Investigator, including major depressive disorder, bipolar illness, or schizophrenia.
• • Participation in another clinical trial of a drug or device
• • Has a body mass index or body weight that will interfere with participation in the trial, including inadequate venous access to complete the trial assessments, to be determined at the discretion of the Investigator.
• • Previous clinically significant systemic illness or infection, including test positive COVID-19, within the past 4 weeks prior to Screening.
• • Clinical diagnosis of Type I or Type II diabetes requiring insulin.
• • Exhibit physical, cognitive, or language impairments, in the opinion of the Investigator, of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.
• • Trial participants with evidence of current infection with HIV, hepatitis B, or hepatitis C.
• • Participants with a history of clinically significant drug abuse or addiction in the past 2 years
• • Evidence or history of alcohol abuse