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

Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
ACW Investigative Site 218
RECRUITING
Carlsbad
ACW Investigative Site 213
RECRUITING
Orange
ACW Investigative Site 209
RECRUITING
Sherman Oaks
Colorado
ACW Investigative Site 211
RECRUITING
Denver
ACW Investigative Site 208
RECRUITING
Englewood
Florida
ACW Investigative Site 203
RECRUITING
Delray Beach
ACW Investigative site 201
RECRUITING
Miami
ACW Investigative site 202
RECRUITING
New Port Richey
ACW Investigative site 204
RECRUITING
Orlando
ACW Investigative site 205
RECRUITING
The Villages
Georgia
ACW Investigative Site 207
RECRUITING
Decatur
New Jersey
ACW Investigative Site 206
RECRUITING
Toms River
New York
ACW Investigative Site 214
RECRUITING
Albany
ACW Investigative Site 219
RECRUITING
Staten Island
Ohio
ACW Investigative Site 210
RECRUITING
Dayton
ACW Investigative Site 217
RECRUITING
Independence
Oregon
ACW Investigative Site 212
RECRUITING
Portland
Rhode Island
ACW Investigative Site 216
RECRUITING
East Providence
Texas
ACW Investigative Site 220
RECRUITING
Austin
Washington
ACW Investigative Site 215
RECRUITING
Bellevue
Other Locations
Australia
ACW Investigative Site 114
RECRUITING
Bedford Park
ACW Investigative Site 113
RECRUITING
Birtinya
ACW Investigative Site 115
RECRUITING
Carlton
ACW Investigative Site 105
RECRUITING
Chermside
ACW Investigative Site 106
RECRUITING
Darlinghurst
ACW Investigative Site 103
RECRUITING
Erina
ACW Investigative Site 101
RECRUITING
Ivanhoe
ACW Investigative Site 102
RECRUITING
Kogarah
ACW Investigative Site 107
RECRUITING
Macquarie Park
ACW Investigative Site 108
RECRUITING
Malvern
ACW Investigative Site 104
RECRUITING
Nedlands
ACW Investigative Site 111
RECRUITING
Newcastle
ACW Investigative Site 112
RECRUITING
Parkville
ACW Investigative Site 109
RECRUITING
West Perth
ACW Investigative Site 110
RECRUITING
Woodville South
Contact Information
Primary
Global Program Lead
clinicaltrials@actinogen.com.au
+61 2 8964 7401
Time Frame
Start Date: 2024-04-12
Estimated Completion Date: 2025-12
Participants
Target number of participants: 220
Treatments
Experimental: 10 mg Xanamem
10 mg Xanamem tablet, to be administered orally once every morning with or without food
Placebo_comparator: Placebo
Placebo tablet, to be administered orally once every morning with or without food
Related Therapeutic Areas
Sponsors
Leads: Actinogen Medical

This content was sourced from clinicaltrials.gov

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