ACTIVE_NOT_RECRUITING

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

Conditions

Dementia Moderate Dementia, Mild Alzheimer Disease Xanamem Actinogen Alzheimer's Disease Cortisol emestedastat

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-04-12

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06125951

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Principal Investigator

Global Program Lead

STUDY_DIRECTOR

Actinogen Medical Ltd

Study Locations (Sites)

ACW Investigative Site 218

Carlsbad, California, 92011

United States

ACW Investigative Site 213

Orange, California, 92866

United States

ACW Investigative Site 209

Sherman Oaks, California, 91403

United States

ACW Investigative Site 211

Denver, Colorado, 80218

United States

ACW Investigative Site 208

Englewood, Colorado, 80113

United States

ACW Investigative Site 203

Delray Beach, Florida, 33445

United States

ACW Investigative site 201

Miami, Florida, 33176

United States

ACW Investigative site 202

New Port Richey, Florida, 34652

United States

ACW Investigative site 204

Orlando, Florida, 32803

United States

ACW Investigative site 205

The Villages, Florida, 32162

United States

ACW Investigative Site 207

Decatur, Georgia, 30030

United States

ACW Investigative Site 206

Toms River, New Jersey, 08755

United States

ACW Investigative Site 214

Albany, New York, 12208

United States

ACW Investigative Site 219

Staten Island, New York, 10314

United States

ACW Investigative Site 210

Dayton, Ohio, 45459

United States

ACW Investigative Site 217

Independence, Ohio, 44131

United States

ACW Investigative Site 212

Portland, Oregon, 97225

United States

ACW Investigative Site 216

East Providence, Rhode Island, 02914

United States

ACW Investigative Site 220

Austin, Texas, 78757

United States

ACW Investigative Site 215

Bellevue, Washington, 98007

United States

Collaborators and Investigators

Sponsor: Actinogen Medical

Global Program Lead, STUDY_DIRECTOR, Actinogen Medical Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-12

Study Completion Date2026-10

Study Record Updates

Study Start Date2024-04-12

Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

Xanamem
Actinogen
Alzheimer's Disease
Cortisol
emestedastat

Additional Relevant MeSH Terms

Dementia Moderate
Dementia, Mild
Alzheimer Disease