Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease
- Conditions
- Alzheimer DiseaseDementia ModerateDementia, Mild
- Interventions
- Drug: Placebo
- Registration Number
- NCT06125951
- Lead Sponsor
- Actinogen Medical
- Brief Summary
Xanamem® is being developed as a potential treatment for symptomatic, early stages of Alzheimer's Disease (AD) and Major Depressive Disorder (MDD).
This XanaMIA Phase 2b/3 study is to investigate the safety, tolerability, and efficacy of Xanamem in in mild or moderate dementia due to AD. Trial participants will be randomized to either receive 10mg of Xanamem once daily or a placebo for 36 weeks at a 1:1 ratio in a double-blinded fashion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
-
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:
- Clinical Dementia Rating (CDR) global score of 0.5 to 1.0
- Mini-mental state examination (MMSE) score of 18 to 26
- 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
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 10 mg Xanamem Xanamem 10 mg Xanamem tablet, to be administered orally once every morning with or without food Placebo Placebo Placebo tablet, to be administered orally once every morning with or without food
- Primary Outcome Measures
Name Time Method Effects of 10 mg Xanamem on integrated cognitive and functional abilities 36 weeks Change from Baseline to end of treatment (EOT) in the Clinical Dementia Ratio - Sum of Boxes (CDR-SB). The CDR-SB is calculated as an average score, with lower scores indicating improvement.
Incidence and severity of treatment-emergent adverse events (TEAEs) [safety and tolerability of Xanamem] 36 weeks Incidence and severity of TEAEs
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
ACW Investigative Site 218
🇺🇸Carlsbad, California, United States
ACW Investigative Site 213
🇺🇸Orange, California, United States
ACW Investigative Site 209
🇺🇸Sherman Oaks, California, United States
ACW Investigative Site 211
🇺🇸Denver, Colorado, United States
ACW Investigative Site 208
🇺🇸Englewood, Colorado, United States
ACW Investigative Site 203
🇺🇸Delray Beach, Florida, United States
ACW Investigative site 201
🇺🇸Miami, Florida, United States
ACW Investigative site 202
🇺🇸New Port Richey, Florida, United States
ACW Investigative site 204
🇺🇸Orlando, Florida, United States
ACW Investigative site 205
🇺🇸The Villages, Florida, United States
ACW Investigative Site 207
🇺🇸Decatur, Georgia, United States
ACW Investigative Site 206
🇺🇸Toms River, New Jersey, United States
ACW Investigative Site 214
🇺🇸Albany, New York, United States
ACW Investigative Site 219
🇺🇸Staten Island, New York, United States
ACW Investigative Site 210
🇺🇸Dayton, Ohio, United States
ACW Investigative Site 217
🇺🇸Independence, Ohio, United States
ACW Investigative Site 212
🇺🇸Portland, Oregon, United States
ACW Investigative Site 216
🇺🇸East Providence, Rhode Island, United States
ACW Investigative Site 220
🇺🇸Austin, Texas, United States
ACW Investigative Site 215
🇺🇸Bellevue, Washington, United States
ACW Investigative Site 106
🇦🇺Darlinghurst, New South Wales, Australia
ACW Investigative Site 103
🇦🇺Erina, New South Wales, Australia
ACW Investigative Site 102
🇦🇺Kogarah, New South Wales, Australia
ACW Investigative Site 107
🇦🇺Macquarie Park, New South Wales, Australia
ACW Investigative Site 111
🇦🇺Newcastle, New South Wales, Australia
ACW Investigative Site 113
🇦🇺Birtinya, Queensland, Australia
ACW Investigative Site 105
🇦🇺Chermside, Queensland, Australia
ACW Investigative Site 114
🇦🇺Bedford Park, South Australia, Australia
ACW Investigative Site 110
🇦🇺Woodville South, South Australia, Australia
ACW Investigative Site 115
🇦🇺Carlton, Victoria, Australia
ACW Investigative Site 101
🇦🇺Ivanhoe, Victoria, Australia
ACW Investigative Site 108
🇦🇺Malvern, Victoria, Australia
ACW Investigative Site 112
🇦🇺Parkville, Victoria, Australia
ACW Investigative Site 104
🇦🇺Nedlands, Western Australia, Australia
ACW Investigative Site 109
🇦🇺West Perth, Western Australia, Australia