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Corticosteroid
Xanamem for Alzheimer's Disease (XanaMIA Trial)
Phase 2
Recruiting
Research Sponsored by Actinogen Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female aged 50 years or older, inclusive at the time of Screening.
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 weeks (baseline to week 36 [eot])
Awards & highlights
Summary
This trial is testing a drug called Xanamem as a potential treatment for early stages of Alzheimer's Disease and Major Depressive Disorder. Participants in the study will either receive 10mg of X
Who is the study for?
This trial is for men and women aged 50 or older with mild to moderate dementia due to Alzheimer's, who have specific biomarkers in their blood. They must have had a brain scan within the last year and show cognitive impairment on tests. Stable medication use for 3 months is required, as well as a partner to attend visits and report on the participant's condition.
What is being tested?
The study tests Xanamem at a dose of 10 mg daily against a placebo over 36 weeks to see if it's safe, tolerable, and effective for early-stage Alzheimer's Disease. Participants are randomly assigned to either treatment or placebo in equal numbers without knowing which they receive (double-blinded).
What are the potential side effects?
Possible side effects of Xanamem are not detailed here but typically could include gastrointestinal issues, headaches, dizziness, or other reactions common with medications affecting brain function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 50 years old or older.
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My recent MRI or CT scan rules out other major causes for my dementia symptoms.
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My blood test shows high levels of a marker linked to Alzheimer's disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 weeks (baseline to week 36 [eot])
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks (baseline to week 36 [eot])
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Effects of 10 mg Xanamem on cognition
Incidence and severity of treatment-emergent adverse events (TEAEs) [safety and tolerability of Xanamem]
Secondary study objectives
Effects of Xanamem on AD biomarker ratios
Effects of Xanamem on attention and working memory
Effects of Xanamem on biomarkers of AD.
+7 moreOther study objectives
Collection of urine for metabolite screening
On-treatment visit PK data to assess compliance
Sparse PK sampling for use in PPK analysis
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: 10 mg XanamemExperimental Treatment1 Intervention
10 mg Xanamem tablet, to be administered orally once every morning with or without food
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet, to be administered orally once every morning with or without food
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Xanamem
2019
Completed Phase 1
~50
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Who is running the clinical trial?
Actinogen MedicalLead Sponsor
5 Previous Clinical Trials
541 Total Patients Enrolled
1 Trials studying Dementia
185 Patients Enrolled for Dementia
Harinder CheraStudy DirectorActinogen Medical Limited
1 Previous Clinical Trials
167 Total Patients Enrolled
Global Program LeadStudy DirectorActinogen Medical Ltd
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