Trial Outcomes & Findings for A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu) (NCT NCT02727699)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

185 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2025-02-03

Participant Flow

Subjects were recruited based on physician referral between March 2017 to November 2018 when enrolment completed. This was a global, multi-center study involving 27 study sites, of which, 24 sites had randomised subjects to the study.The study planned to enrol 7 to 10 subjects at each study site.

It was planned that approximately 174 subjects would be enrolled to ensure 156 subjects would complete the 12 week double-blind study period (78 subjects in each treatment group). At study-end, in total, 457 subjects were screened, of whom 185 subjects were randomised (91:94 Xanamem to placebo) to the study with 171 subjects completed.

Participant milestones

Participant milestones
Measure	Xanamem™ Oral Xanamem™ capsules 10mg, to be administered once daily Xanamem™: 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 (Laboratory code for Xanamem)	Placebo Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules
Overall Study STARTED	91	94
Overall Study COMPLETED	82	89
Overall Study NOT COMPLETED	9	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Xanamem™ Oral Xanamem™ capsules 10mg, to be administered once daily Xanamem™: 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 (Laboratory code for Xanamem)	Placebo Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules
Overall Study Adverse Event	2	0
Overall Study Withdrawal by Subject	5	3
Overall Study Protocol Violation	0	1
Overall Study Physician Decision	0	1
Overall Study Lost to Follow-up	1	0
Overall Study Sponsor Decision	1	0

Baseline Characteristics

Number of subjects in the specified category with non-missing values in the Full Analysis Set (FAS).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Xanamem™ n=91 Participants Oral Xanamem™ capsules 10mg, to be administered once daily Xanamem™: 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 n=94 Participants Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules	Total n=185 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	24 Participants n=7 Participants	43 Participants n=5 Participants
Age, Categorical >=65 years	72 Participants n=5 Participants	70 Participants n=7 Participants	142 Participants n=5 Participants
Age, Continuous	71.3 years STANDARD_DEVIATION 8.71 • n=5 Participants	70.8 years STANDARD_DEVIATION 8.20 • n=7 Participants	71.0 years STANDARD_DEVIATION 8.43 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	54 Participants n=7 Participants	106 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	40 Participants n=7 Participants	79 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	65 Participants n=5 Participants	74 Participants n=7 Participants	139 Participants n=5 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants	55 participants n=7 Participants	108 participants n=5 Participants
Region of Enrollment United Kingdom	14 participants n=5 Participants	15 participants n=7 Participants	29 participants n=5 Participants
Region of Enrollment Australia	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants
Height	165.49 centimetres (cm) STANDARD_DEVIATION 9.665 • n=5 Participants • Number of subjects in the specified category with non-missing values in the Full Analysis Set (FAS).	166.36 centimetres (cm) STANDARD_DEVIATION 8.964 • n=7 Participants • Number of subjects in the specified category with non-missing values in the Full Analysis Set (FAS).	165.94 centimetres (cm) STANDARD_DEVIATION 9.295 • n=5 Participants • Number of subjects in the specified category with non-missing values in the Full Analysis Set (FAS).
Body Mass Index (BMI)	27.31 kilogram / square meter (kg/m^2) STANDARD_DEVIATION 5.024 • n=5 Participants • Baseline value is defined as the latest observation prior to or on the date of the first dose of study drug.	27.08 kilogram / square meter (kg/m^2) STANDARD_DEVIATION 6.570 • n=7 Participants • Baseline value is defined as the latest observation prior to or on the date of the first dose of study drug.	27.19 kilogram / square meter (kg/m^2) STANDARD_DEVIATION 5.855 • n=5 Participants • Baseline value is defined as the latest observation prior to or on the date of the first dose of study drug.
Weight	74.90 kilogram (kg) STANDARD_DEVIATION 15.964 • n=5 Participants	74.88 kilogram (kg) STANDARD_DEVIATION 18.774 • n=7 Participants	74.89 kilogram (kg) STANDARD_DEVIATION 17.424 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: The ADAS-cog v14 includes the following 14 items, with a Total scoring range of 0 - 90. Higher scores indicate greater disease severity

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.

Outcome measures

Outcome measures
Measure	Xanamem™ n=86 Participants Oral Xanamem™ capsules 10mg, to be administered once daily Xanamem™: 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 n=92 Participants Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules
ADAS-Cog v14	-1.5 units on a scale Standard Deviation 6.47	-0.7 units on a scale Standard Deviation 6.65

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: ADCOMs, composite score (0 - 1.97) is derived from ADAS-Cog v14, CDR-SOB, and MMSE. Analysis of Change from Baseline to Week 12/end of treatment (EOT) in ADCOMs from the Full Analysis Set (FAS).

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.

Outcome measures

Outcome measures
Measure	Xanamem™ n=86 Participants Oral Xanamem™ capsules 10mg, to be administered once daily Xanamem™: 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 n=92 Participants Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules
AD COMposite Scores	0.02472 score on a scale Standard Deviation 0.144135	0.01908 score on a scale Standard Deviation 0.151502

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Analysis of Change from Baseline to Week 12/EOT in RAVLT from the Full Analysis Set (FAS).

Change in Rey Auditory Verbal Learning Test (RAVLT) RAVLT will be administered using five trials, with individual scores from 0-15. The total score is the combined score of all five trials, ranging from 0 to 75, whereas a lower score is considered a worse outcome and a higher score a better outcome.

Outcome measures

Outcome measures
Measure	Xanamem™ n=86 Participants Oral Xanamem™ capsules 10mg, to be administered once daily Xanamem™: 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 n=92 Participants Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules
RAVLT Recall List A - Total number of correct words	0.3 score on a scale Standard Deviation 6.54	0.4 score on a scale Standard Deviation 6.31
RAVLT Recall List B - Number of correct words	0.3 score on a scale Standard Deviation 1.63	0.1 score on a scale Standard Deviation 1.30
RAVLT Final recall of List A - Number of correct words	0.2 score on a scale Standard Deviation 3.14	0.4 score on a scale Standard Deviation 2.40

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: CDR-SOB score (0 - 18) is a sum of all six items of CDR-SOB. CDR-SOB score will be analysed for each visit as actual values and change from Baseline.

Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SOB) The CDR is obtained through semi-structured interviews of patients and informants, and cognitive functioning is rated in six domains of functioning: memory, orientation, judgement and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a five-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment. The CDR-SOB is based on summing each of the domain box scores, with scores ranging from 0-18, whereas lower scores represent better outcomes and higher scores worse outcomes.

Outcome measures

Outcome measures
Measure	Xanamem™ n=85 Participants Oral Xanamem™ capsules 10mg, to be administered once daily Xanamem™: 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 n=91 Participants Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules
CDR-SOB	0.25 score on a scale Standard Deviation 1.276	0.16 score on a scale Standard Deviation 1.325

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: MMSE is a 30 point questionnaire used to screen for dementia and to estimate the severity and progression of cognitive impairment. MMSE will be analysed for each visit as actual values and change from Baseline.

Change in Mini-Mental Status Examination (MMSE) MMSE total score (0 - 30) is a sum of all 30 point questionnaire of MMSE. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia.

Outcome measures

Outcome measures
Measure	Xanamem™ n=86 Participants Oral Xanamem™ capsules 10mg, to be administered once daily Xanamem™: 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 n=91 Participants Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules
MMSE	0.2 score on a scale Standard Deviation 3.09	-0.2 score on a scale Standard Deviation 2.85

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: The NPI total score is calculated by multiplying the frequency and severity rates per domain (maximum score per domain is 12) and then calculating the total of all domains (total NPI-score minimum is 0 and maximum 144). Total distress score (0 - 60) will summarised descriptively. NPI total score will not be calculated if any sub item is missing.

Change in Neuropsychiatric Inventory (NPI) The NPI includes questions to ten behavioural and two neurodegenerative domains. Raters recorded neuropsychiatric symptoms using a 1-4 scale for frequency and a 1-3 scale for severity for each item in the instrument, with the score for each domain being: domain score = frequency x severity. The total score is calculated by adding the scores of the first 10 domain scores. The two neurodegenerative items are not included in the NPI total score as they form part of the depression syndrome in some patients and were specifically excluded from the dysphoria subscale of the NPI in order to allow that subscale to focus on mood symptoms. The total NPI-score minimum is 0 and the maximum 144. A lower score is considered a better outcome, a higher score a worse outcome.

Outcome measures

Outcome measures
Measure	Xanamem™ n=85 Participants Oral Xanamem™ capsules 10mg, to be administered once daily Xanamem™: 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 n=92 Participants Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules
NPI (Neuropsychiatric Inventory) NPI Total Score	0.9 units on a scale Standard Deviation 8.67	0.8 units on a scale Standard Deviation 9.09
NPI (Neuropsychiatric Inventory) Delusions	0.0 units on a scale Standard Deviation 0.38	0.1 units on a scale Standard Deviation 0.87
NPI (Neuropsychiatric Inventory) Hallucinations	0.1 units on a scale Standard Deviation 0.60	0.0 units on a scale Standard Deviation 0.36
NPI (Neuropsychiatric Inventory) Agitation/Aggression	0.2 units on a scale Standard Deviation 2.02	0.2 units on a scale Standard Deviation 1.91
NPI (Neuropsychiatric Inventory) Depression/Dysphoria	0.0 units on a scale Standard Deviation 1.34	0.0 units on a scale Standard Deviation 1.91
NPI (Neuropsychiatric Inventory) Anxiety	0.1 units on a scale Standard Deviation 1.70	-0.4 units on a scale Standard Deviation 2.08
NPI (Neuropsychiatric Inventory) Elation/Euphoria	0.1 units on a scale Standard Deviation 0.92	0.0 units on a scale Standard Deviation 0.67
NPI (Neuropsychiatric Inventory) Disinhibition	0.1 units on a scale Standard Deviation 1.15	0.1 units on a scale Standard Deviation 1.03
NPI (Neuropsychiatric Inventory) Irritability/Lability	0.1 units on a scale Standard Deviation 1.94	0.5 units on a scale Standard Deviation 2.17
NPI (Neuropsychiatric Inventory) Aberrant Motor Behavior	-0.1 units on a scale Standard Deviation 2.98	0.2 units on a scale Standard Deviation 2.37
NPI (Neuropsychiatric Inventory) Sleep	0.2 units on a scale Standard Deviation 2.47	0.0 units on a scale Standard Deviation 1.83
NPI (Neuropsychiatric Inventory) Appetite and Eating Disorders	0.1 units on a scale Standard Deviation 3.18	-0.1 units on a scale Standard Deviation 2.02
NPI (Neuropsychiatric Inventory) Apathy/Indifference	0.0 units on a scale Standard Deviation 2.18	0.3 units on a scale Standard Deviation 2.11

SECONDARY outcome

Timeframe: Baseline, Week 12

Population: Total NTB score is the sum of 'Total correct response' of Category Fluency Test (CFT) and 'Total number of correct words' of Controlled Oral Word Association Test (COWAT). Each score ('Total correct response' of CFT and 'Total number of correct word' of COWAT) will also be analysed.

Change in Neuropsychological Test Batteries (NTB) - Executive Domains: Controlled Oral Word Association - Test (COWAT) and Total Correct Response (CFT) Total NTB score is the sum of COWAT and CFT. During the COWAT test, the subject is asked to mention as many words as possible beginning with different letters (F, A, S) within 1 minute each. The number of words for each letter is recorded, the score is the sum of all words. There is no minimum or maximum score, whereas more words indicate a better outcome. During the CFT test, the subject is given 1 minute to produce as many unique words as possible within a semantic category. The subject's score is the number of unique correct words. There is no minimum or maximum score whereas a score of under 14 is interpreted as concerning regarding cognition.

Outcome measures

Outcome measures
Measure	Xanamem™ n=86 Participants Oral Xanamem™ capsules 10mg, to be administered once daily Xanamem™: 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 n=91 Participants Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules
NTB - Executive Domain COWAT Total Correct Words	0.5 score on a scale Standard Deviation 8.08	0.5 score on a scale Standard Deviation 8.12
NTB - Executive Domain CTF Total Correct Responses	0.3 score on a scale Standard Deviation 8.53	-0.7 score on a scale Standard Deviation 6.28
NTB - Executive Domain NTB Total Score	0.8 score on a scale Standard Deviation 11.50	-0.2 score on a scale Standard Deviation 9.84

Adverse Events

Xanamem™

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Xanamem™ n=91 participants at risk Oral Xanamem™ capsules 10mg, to be administered once daily Xanamem™: 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 n=94 participants at risk Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules
Cardiac disorders Acute myocardial infarction	0.00% 0/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	1.1% 1/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Infections and infestations Pneumonia	2.2% 2/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	0.00% 0/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Infections and infestations Influenza	0.00% 0/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	1.1% 1/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Injury, poisoning and procedural complications Fall	0.00% 0/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	1.1% 1/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Injury, poisoning and procedural complications Rib Fracture	0.00% 0/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	1.1% 1/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Investigations Vibration test abnormal	1.1% 1/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	0.00% 0/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	1.1% 1/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	0.00% 0/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Nervous system disorders Transient Ischaemic Attack	0.00% 0/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	1.1% 1/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Respiratory, thoracic and mediastinal disorders Pulmonary Cavitation	1.1% 1/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	0.00% 0/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.

Other adverse events

Other adverse events
Measure	Xanamem™ n=91 participants at risk Oral Xanamem™ capsules 10mg, to be administered once daily Xanamem™: 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 n=94 participants at risk Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily Placebo (for Xanamem™): Excipient blend capsules manufactured to mimic Xanamem™ capsules
Nervous system disorders Headache	9.9% 9/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	10.6% 10/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Infections and infestations Urinary tract infection	6.6% 6/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	2.1% 2/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Musculoskeletal and connective tissue disorders Pain in extremity	1.1% 1/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	5.3% 5/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Gastrointestinal disorders Diarrhoea	6.6% 6/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	5.3% 5/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Injury, poisoning and procedural complications Fall	3.3% 3/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	6.4% 6/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.
Nervous system disorders Dizziness	8.8% 8/91 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.	4.3% 4/94 • Median treatment duration (weeks) was 12 weeks (range: 0.14, 13.0 weeks) for subjects in the Xanamem group and 12 weeks (range: 0.14, 13.1 weeks) for subjects in the placebo group.

Additional Information

Director of Drug Development & Strategy

Actinogen Medical Limited

Phone: +61289647401

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER