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NCT06125951 | RECRUITING | Dementia Moderate

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

Condition or disease

Dementia Moderate

Dementia, Mild

Alzheimer Disease

Intervention/treatment

Xanamem

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 220 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Phase 2b/3, Double-Blind, Placebo-Controlled, Parallel-Group, 36-Week, 2-Arm Trial to Assess the Safety, Tolerability, and Efficacy of Xanamem® 10 mg Daily in Patients With Mild or Moderate Dementia Due to Alzheimer's Disease
Actual Study Start Date : 2024-04-12
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease

Location Details

NCT06125951

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

ACW Investigative Site 218

Carlsbad, California, United States, 92011

RECRUITING

United States, California

ACW Investigative Site 213

Orange, California, United States, 92866

RECRUITING

United States, California

ACW Investigative Site 209

Sherman Oaks, California, United States, 91403

RECRUITING

United States, Colorado

ACW Investigative Site 211

Denver, Colorado, United States, 80218

RECRUITING

United States, Colorado

ACW Investigative Site 208

Englewood, Colorado, United States, 80113

RECRUITING

United States, Florida

ACW Investigative Site 203

Delray Beach, Florida, United States, 33445

RECRUITING

United States, Florida

ACW Investigative site 201

Miami, Florida, United States, 33176

RECRUITING

United States, Florida

ACW Investigative site 202

New Port Richey, Florida, United States, 34652

RECRUITING

United States, Florida

ACW Investigative site 204

Orlando, Florida, United States, 32803

RECRUITING

United States, Florida

ACW Investigative site 205

The Villages, Florida, United States, 32162

RECRUITING

United States, Georgia

ACW Investigative Site 207

Decatur, Georgia, United States, 30030

RECRUITING

United States, New Jersey

ACW Investigative Site 206

Toms River, New Jersey, United States, 08755

RECRUITING

United States, New York

ACW Investigative Site 214

Albany, New York, United States, 12208

RECRUITING

United States, New York

ACW Investigative Site 219

Staten Island, New York, United States, 10314

RECRUITING

United States, Ohio

ACW Investigative Site 210

Dayton, Ohio, United States, 45459

RECRUITING

United States, Ohio

ACW Investigative Site 217

Independence, Ohio, United States, 44131

RECRUITING

United States, Oregon

ACW Investigative Site 212

Portland, Oregon, United States, 97225

RECRUITING

United States, Rhode Island

ACW Investigative Site 216

East Providence, Rhode Island, United States, 02914

RECRUITING

United States, Texas

ACW Investigative Site 220

Austin, Texas, United States, 78757

RECRUITING

United States, Washington

ACW Investigative Site 215

Bellevue, Washington, United States, 98007

RECRUITING

Australia, New South Wales

ACW Investigative Site 106

Darlinghurst, New South Wales, Australia,

RECRUITING

Australia, New South Wales

ACW Investigative Site 103

It has, New South Wales, Australia,

RECRUITING

Australia, New South Wales

ACW Investigative Site 102

Kogarh, New South Wales, Australia,

RECRUITING

Australia, New South Wales

ACW Investigative Site 107

Macquarie Park, New South Wales, Australia,

RECRUITING

Australia, New South Wales

ACW Investigative Site 111

Newcastle, New South Wales, Australia,

RECRUITING

Australia, Queensland

ACW Investigative Site 113

Birtinya, Queensland, Australia,

RECRUITING

Australia, Queensland

ACW Investigative Site 105

Chermside, Queensland, Australia,

RECRUITING

Australia, South Australia

ACW Investigative Site 114

Bedford Park, South Australia, Australia,

RECRUITING

Australia, South Australia

ACW Investigative Site 110

Woodville South, South Australia, Australia,

RECRUITING

Australia, Victoria

ACW Investigative Site 115

Carlton, Victoria, Australia,

RECRUITING

Australia, Victoria

ACW Investigative Site 101

Ivanhoe, Victoria, Australia,

RECRUITING

Australia, Victoria

ACW Investigative Site 108

Malvern, Victoria, Australia,

RECRUITING

Australia, Victoria

ACW Investigative Site 112

Parkville, Victoria, Australia,

RECRUITING

Australia, Western Australia

ACW Investigative Site 104

Nedlands, Western Australia, Australia,

RECRUITING

Australia, Western Australia

ACW Investigative Site 109

West Perth, Western Australia, Australia,