Clinical trial NCT06125951: Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dementia Moderate
Dementia, Mild
Alzheimer Disease
Keywords: Xanamem
Actinogen
Alzheimer's Disease
Cortisol
emestedastat
Lead sponsor: Actinogen Medical
Sponsor class: INDUSTRY
First posted: 2023-11-09
Enrollment: 220
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Effects of 10 mg Xanamem on integrated cognitive and functional abilities
timeFrame: 36 weeks
measure: Incidence and severity of treatment-emergent adverse events (TEAEs) [safety and tolerability of Xanamem]
timeFrame: 36 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: ACW Investigative Site 218
state: California
city: Orange
country: United States
facility: ACW Investigative Site 213
state: California
city: Sherman Oaks
country: United States
facility: ACW Investigative Site 209
state: California
city: Denver
country: United States
facility: ACW Investigative Site 211
state: Colorado
city: Englewood
country: United States
facility: ACW Investigative Site 208
state: Colorado
city: Delray Beach
country: United States
facility: ACW Investigative Site 203
state: Florida
city: Miami
country: United States
facility: ACW Investigative site 201
state: Florida
city: New Port Richey
country: United States
facility: ACW Investigative site 202
state: Florida
city: Orlando
country: United States
facility: ACW Investigative site 204
state: Florida
city: The Villages
country: United States
facility: ACW Investigative site 205
state: Florida
city: Decatur
country: United States
facility: ACW Investigative Site 207
state: Georgia
city: Toms River
country: United States
facility: ACW Investigative Site 206
state: New Jersey
city: Albany
country: United States
facility: ACW Investigative Site 214
state: New York
city: Staten Island
country: United States
facility: ACW Investigative Site 219
state: New York
city: Dayton
country: United States
facility: ACW Investigative Site 210
state: Ohio
city: Independence
country: United States
facility: ACW Investigative Site 217
state: Ohio
city: Portland
country: United States
facility: ACW Investigative Site 212
state: Oregon
city: East Providence
country: United States
facility: ACW Investigative Site 216
state: Rhode Island
city: Austin
country: United States
facility: ACW Investigative Site 220
state: Texas
city: Bellevue
country: United States
facility: ACW Investigative Site 215
state: Washington
city: Darlinghurst
country: Australia
facility: ACW Investigative Site 106
state: New South Wales
city: Erina
country: Australia
facility: ACW Investigative Site 103
state: New South Wales
city: Kogarah
country: Australia
facility: ACW Investigative Site 102
state: New South Wales
city: Macquarie Park
country: Australia
facility: ACW Investigative Site 107
state: New South Wales
city: Newcastle
country: Australia
facility: ACW Investigative Site 111
state: New South Wales
city: Birtinya
country: Australia
facility: ACW Investigative Site 113
state: Queensland
city: Chermside
country: Australia
facility: ACW Investigative Site 105
state: Queensland
city: Bedford Park
country: Australia
facility: ACW Investigative Site 114
state: South Australia
city: Woodville South
country: Australia
facility: ACW Investigative Site 110
state: South Australia
city: Carlton
country: Australia
facility: ACW Investigative Site 115
state: Victoria
city: Ivanhoe
country: Australia
facility: ACW Investigative Site 101
state: Victoria
city: Malvern
country: Australia
facility: ACW Investigative Site 108
state: Victoria
city: Parkville
country: Australia
facility: ACW Investigative Site 112
state: Victoria
city: Nedlands
country: Australia
facility: ACW Investigative Site 104
state: Western Australia
city: West Perth
country: Australia
facility: ACW Investigative Site 109
state: Western Australia
Study officials:
affiliation: Actinogen Medical Ltd
name: Global Program Lead
role: STUDY_DIRECTOR
References: