Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Xanamem · 2 trials · 10 indications
Change in Alzheimer's Disease Assessment Scales - Cognitive Subscale Score, version 14 (ADAS-Cog v14) Total scores of ADAS Cog 14 range from 0 to 90, with higher scores indicating greater disease severity.
Change in AD COMposite Scores (ADCOMs- ADCOMs, composite score is derived from a weighted linear combination of items from commonly used outcome scales Cognitive Subscale Version 14 \[ADAS-Cog v14\], Clinical Dementia Rating Scale - Sum of Boxes \[CDR-SOB\], and Mini-Mental Status Examination \[MMSE\]. Th ADCOMs range: 0 - 1.97, whereas a lover score is interpreted as a better result. Included scales: ADAS-Cog v14 (range: 0-90): A lower score is indicative of better cognition, a higher score indicates higher cognitive impairment. CDR-SOB (range: 0-18): A lower score is indicative of better cognition, a higher score indicates higher cognitive impairment. MMSE (range: 0-30): A higher score is indicative of better cognition, a lower score indicates higher cognitive impairment.
The number, type, and severity of treatment-emergent adverse events (AEs) that are reported from Screening Visit to Follow-up Visit will be collected and evaluated.
Collection of blood samples for clinical laboratory testing to assess any clinically significant changes in standard serum chemistry measures.
Collection of blood samples for clinical laboratory testing to assess any clinically significant changes in standard haematology measures.
Evaluation of any clinically significant changes or abnormalities reported following a standard Physical Examination.
Nerve Conduction assessments will be used to detect presence and severity of nerve damage.
Changes in the Neuropathy Total Symptom Score (NTSS-6) administered by a physician to assess a subjects' medical history. Each item will also be graded for its frequency and intensity, adding up to a total score from "0" to "21.96" points. A total score of \> 6 would exclude the subject from the study.
Changes in Toronto Clinical Neuropathy Score (TCNS) to detect for neuropathy out of a total score of 19; scales are defined as follows: 0-5 = no neuropathy; 6-8 = mild neuropathy; 9-11 = moderate neuropathy; ≥ 12 = severe neuropathy.
A 3mm skin sample will be taken via skin punch biopsy to detect intra-epidermal nerve fiber density; this allows for the objectification and quantification of a small-fiber neuropathy.
Thermal sensory testing using Quantitative Sensory Testing (QST) for cold, warm and heat pain to detect peripheral nerve disorders.
Any change in Columbia Suicide Severity Rating Scale (CSSRS) will assess suicidal ideation and behaviour. * Suicidal ideation score: Any score greater than 0 is important and may indicate the need for mental health intervention. * Suicidal ideation intensity rating: The five intensity item scores create a total score (range 0 to 25) to represent the intensity rating, if the patient did not endorse any suicidal ideation the intensity rating is 0.
Any clinically significant electrocardiogram (ECG) abnormalities will be recorded, including corrected QT interval (QTc) of \> 500 msec.
| Arm | Type | Description |
|---|---|---|
| Xanamem™ | EXPERIMENTAL | Oral Xanamem™ capsules 10mg, to be administered once daily |
| Placebo | PLACEBO_COMPARATOR | Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily |
| Cohort 1 / Cohort 2 (Active) | EXPERIMENTAL | 20mg or 30mg capsules of Xanamem respectively, to be administered PO once daily. |
| Cohort 1 / Cohort 2 (Placebo) | PLACEBO_COMPARATOR | Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily. |
| Name | Type | Description |
|---|---|---|
| Xanamem™ | DRUG | Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343 |
| Placebo (for Xanamem™) | DRUG | Excipient blend capsules manufactured to mimic Xanamem™ capsules |
| Xanamem | DRUG | Oral Xanamem capsules 20mg or 30mg, administered PO once daily. Xanamem is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343. |
| Matching Placebo | DRUG | Matching placebo which is identical in appearance to the test product (20mg, 30mg Xanamem™ QD) except that it contains no active ingredient. |
Inclusion Criteria: 1. Males and females aged 50 years or older at the time of informed consent. 2. Female Subjects: 1. Post menopausal women, defined as no menses for 12 months without an alternative medical cause. If there is any concern about the menopausal status of a prospective female sub...
Xanamem is an investigational small molecule being studied for the treatment of mild dementia due to Alzheimer's disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety, tolerability, and efficacy in patients with this condition.
Xanamem is a small molecule designed to inhibit the enzyme 11β-HSD1, which is involved in the production of cortisol within the brain. By reducing local cortisol levels, Xanamem aims to address cognitive decline associated with Alzheimer's disease. This mechanism is being investigated in clinical trials for its potential to improve cognitive function.
Xanamem is being developed by Icon Plc, a biopharmaceutical company listed on the NASDAQ under the ticker symbol ICLR. The company is conducting clinical trials to evaluate the drug's safety and efficacy for Alzheimer's disease and related conditions.
Xanamem is currently in Phase 2 clinical development. It has completed a Phase 2 study in patients with mild dementia due to Alzheimer's disease and a Phase 1 study in healthy elderly subjects. The drug remains investigational and is not yet approved for any use.
Xanamem has been studied in two completed clinical trials. The Phase 2 trial NCT02727699, known as XanADu, enrolled 185 patients with mild dementia due to Alzheimer's disease across the United States, Australia, and the United Kingdom. The Phase 1 trial NCT03830762 enrolled 42 healthy elderly subjects in Australia to assess safety and cognitive effects.
Xanamem is a distinct investigational drug and is not known to be the same as any other marketed medication. It is being developed under its own name by Icon Plc and is not a repurposed version of an existing approved drug.