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CompletedNCT02727699XanADuUpdated Feb 3, 2025Results posted

A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu)

A Phase 2 interventional study of Xanamem™ and Placebo (for Xanamem™) in Dementia, Alzheimer Type, sponsored by Actinogen Medical. Completed at 25 sites in 3 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-02-03.

Sponsored by Actinogen Medical · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
185
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

This XanADu Phase II study in mild Alzheimer's Disease (AD) is to assess the safety, tolerability and efficacy of Xanamem in subjects with mild dementia due to Alzheimer's Disease. Subjects will be randomized to receive either 10mg once daily Xanamem or Placebo at a 1:1 ratio in a double-blinded fashion.

Read the detailed description

This is a Phase II, randomised, multi-centre, double-blind, placebo-controlled proof-of-concept study to assess the safety, tolerability and efficacy of oral Xanamem once daily in adult subjects with mild dementia due to AD.

Based on Xanamem's mode of action on hippocampal function, amnestic symptoms may respond best, thus favouring the inclusion of mild dementia due to AD, with given evidence of disease progression. Subjects will be treated in a double-blind fashion, where both the investigators and subjects will be unaware of the treatment assignments, to minimise any subjective or unrecognised bias carried by the investigators and subjects. Placebo will be used as the comparator in this study.

It is planned to randomise approximately 174 subjects at approximately 25 study sites in three countries (Australia, United Kingdom, and United States), with the aim to enrol 7 to 10 subjects at each study site. Subject enrolment will be competitive but a cap of 20 subjects per study site is to be established to avoid any side effects. In case the sample composition at one study site is creating concerns, an enrolment stop can also occur at fewer than 20 subjects.

At study end, a total of 185 subjects were randomised into this study and received active treatment.

The data safety monitoring board (DSMB) will periodically meet for the review of accumulating safety study data and will also be involved in the interim analysis.

At the Baseline visit (Week 0), eligible subjects will be randomised on a 1:1 ratio to receive either Xanamem administered orally once daily (QD) for the treatment group or matching placebo for the placebo group. Subjects will return to the study site for visits at Week 4 and Week 8, End of Treatment (Week 12) and Follow-up (4 weeks post last dose of study drug) visits, at which study assessments will be performed.

Ad hoc telephone contact may also occur at any other time-point throughout the study, if deemed necessary by the investigator/study nurse, or if the subject wishes to report an Adverse Event (AE)

Subjects will be interviewed and examined at the study site at each visit and will complete a variety of questionnaires and routine safety evaluations.

Optional Pharmacodynamic (PD) sampling will be performed at specific visits. Subjects who do not provide consent for this optional sub-study will still be eligible for the main study.

The overall study duration for an individual subject will be 17 to 20 weeks, including a screening period of one to 4 weeks, a double-blind treatment period of 12 weeks, and a follow-up period of 4 weeks. The total duration of the study is expected to be 2 years.

02

Conditions studied

  • Dementia, Alzheimer Type

Keywords

  • Dementia
  • Alzheimer's Disease
  • Xanamem
  • UE2343 (Laboratory Code for Xanamem)
  • Cortisol
  • XanADu
  • Actinogen
  • 11β-HSD1
  • 11-beta-Hydroxysteroid Dehydrogenase Type 1
  • Mild Alzheimer's Disease
  • Cognitive Impairments
  • emestedastat
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 185 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Actinogen Medical is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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 subject, a follicle stimulating hormone test (FSH) should be requested to confirm post-menopausal status. Post menopausal women confirmed by FSH level > 40 mIU (milli-international units per milliliter) /mL, will be confirmed by central laboratory.
    2. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening and Baseline, and be willing to use highly effective methods of contraception from the Screening visit until 3 months after last dose of study drug. If re-test is required, a local urine pregnancy test will be performed at Baseline to determine if the subject can continue to randomisation.
    3. Are permanently sterile or have had a hysterectomy, bilateral salpingectomy or bilateral oophorectomy.
    4. Women must not be breastfeeding.

  3. Male Subjects:

    1. Who are sexually active, fertile men must use highly effective methods of contraception from Day 1 until 3 months after last dose of study drug if their partners are WOCBP.
    2. Who are permanently sterile or have had bilateral orchiectomy.
  4. Diagnosis of mild dementia due to Alzheimer's disease (AD) with increased level of certainty (provided by evidence of clinical deterioration within the 6 months preceding Screening, as assessed by the investigator) as determined by the National Institute of Ageing (NIA) and the Alzheimer's Association (AA) workgroup.
  5. Mild dementia due to probable AD with Mini-Mental Status Examination (MMSE) 20 to 26 (inclusive).
  6. Clinical Dementia Rating Scale (CDR) Global Score of 0.5 to 1.0.
  7. A brain magnetic resonance imaging (MRI) or computed tomography (CT) scan in the 12 months preceding Screening that in the investigator's opinion is consistent with AD as the principle aetiology of the dementia with no other clinically significant abnormality, e.g. another principle underlying aetiology of the subject's dementia, or a lesion which could affect cognition e.g. a brain tumour or large stroke.
  8. On stable dose of acetylcholinesterase (AChEI) and/or memantine (at least 3 months prior to Screening) OR treatment-naïve. Initiating AChEIs or memantine during the study will not be permitted.
  9. Apart from a clinical diagnosis of mild dementia due to AD, the subject must be in good health as determined by the investigator, based on medical history and screening assessments.
  10. Has a consenting study partner who, in the investigator's judgement, has frequent and sufficient contact with the subject to be able to provide accurate information as to the subject's cognitive and functional abilities. The study partner must be available to provide information to the investigator and study site staff about the subject and agrees to attend all study site visits in person for scale completion. A study partner should be available for the duration of the study. The measure of adequate availability will be at the investigator's discretion.
  11. Must be willing and able to comply with the requirements of the protocol and must be available to complete the study.
  12. Must satisfy a medical examiner about their fitness to participate in the study.
  13. Must provide written informed consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

  1. Clinically significant abnormalities in vital signs (blood pressure, heart rate, respiration rate and oral temperature), as determined by the investigator.
  2. Clinically significant abnormal haematology, biochemistry and urine examination values, specifically abnormal liver and renal function and Vitamin B12 levels below lower threshold since these parameters may impact cognitive function, as determined by the investigator.
  3. Has had a significant systematic illness or infection within the past 4 weeks prior to randomisation, as determined by the investigator.
  4. Clinically significant neurological disease other than AD, such as (but not limited to) Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumour, progressive supranuclear palsy, seizure disorder, subdural haematoma, multiple sclerosis or a history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
  5. Subjects with clinical evidence of peripheral neuropathy or historical evidence of clinically significant nerve conduction abnormalities.
  6. Has had a stroke within the year prior to randomisation, as determined by the investigator.
  7. Has a lifetime diagnosis of a major psychiatric disorder (other than dementia), based on the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria. This includes but is not limited to schizophrenia, schizoaffective disorder, bipolar affective disorder, alcohol dependence syndrome or major depressive disorder.
  8. Has a history of disease directly related to the hypothalamus, the pituitary and/or the adrenal glands which affect the hypothalamic-pituitary-adrenal axis function.
  9. Has uncontrolled clinical conditions relating to glucose and lipid metabolism.
  10. Clinically significant electrocardiogram (ECG) abnormalities, including Corrected QT interval (QTc) > 450 ms, following ECG tracings at Screening.
  11. Use of any prohibited medication as detailed in the study protocol.
  12. Participation in another clinical study of an investigational drug or device whereby the last investigational drug/device administration is within 60 days of Screening.
  13. Inability to communicate well with the investigator (i.e. language problem, non-fluent English [as scales will be provided in English only], poor mental development or impaired cerebral function).
  14. Subject will undergo the tests, Alzheimer's Disease Assessment Scales (ADAS)-Cog v14, CDR-Sum of Boxes (SOB), MMSE, Neuropsychological Test Battery (NTB; executive domain) and RAVLT at the indicated time-points to avoid uncontrolled learning effects. Subjects who need to perform these tests externally to and in parallel with this study will be excluded.
  15. Subject has ingested any food or drink containing grapefruit, Seville oranges, star fruit or derived products (e.g. fruit juice), for at least 3 days prior to the first administration of study drug.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
185 participants (actual)

Study arms

  • Experimental
    Xanamem™

    Oral Xanamem™ capsules 10mg, to be administered once daily

    Drug: Xanamem™

  • Placebo comparator
    Placebo

    Matching placebo which is identical in appearance to the test product except that it contains no active ingredient, to be administered once daily

    Drug: Placebo (for Xanamem™)

Interventions

  • DrugXanamem™

    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

    Also known as: UE2343

  • DrugPlacebo (for Xanamem™)

    Excipient blend capsules manufactured to mimic Xanamem™ capsules

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. ADAS-Cog v14

    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.

    Time frame: Baseline, Week 12

  2. AD COMposite Scores

    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.

    Time frame: Baseline, Week 12

Secondary outcomes

  1. RAVLT

    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.

    Time frame: Baseline, Week 12

  2. CDR-SOB

    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.

    Time frame: Baseline, Week 12

  3. MMSE

    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.

    Time frame: Baseline, Week 12

  4. NPI (Neuropsychiatric Inventory)

    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.

    Time frame: Baseline, Week 12

  5. NTB - Executive Domain

    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.

    Time frame: Baseline, Week 12

Other outcomes

  1. Pregnancy Test

    Women of childbearing potential only. Serum pregnancy test at screening and a urine pregnancy test at all subsequent clinic visits

    Time frame: Screening, baseline, Week 4, Week, 8, Week 12, Week 16

  2. Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Testosterone

    This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit

    Time frame: Screening, baseline, Week 4, Week, 8, Week 12, Week 16

  3. Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Androstenedione

    This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit

    Time frame: Screening, baseline, Week 4, Week, 8, Week 12, Week 16

  4. Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Dehydroepiandrosterone Sulfate (DHEAS)

    This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit

    Time frame: Screening, baseline, Week 4, Week, 8, Week 12, Week 16

  5. Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Adrenocorticotropic Hormone (ACTH)

    This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit

    Time frame: Screening, baseline, Week 4, Week, 8, Week 12, Week 16

  6. Change in Pharmacokinetics (PK), Including Analysis of Cortisol Levels

    This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit

    Time frame: Baseline, Week 4, Week 8, Week 12 and Unscheduled Safety Visit

  7. NTSS-6

    Change in Neuropathy Total Symptom Score (NTSS-6)

    Time frame: Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Ad Hoc and Unscheduled Safety Visit

  8. NFM

    Change in Nerve Function Monitoring (NFM)

    Time frame: Screening, Baseline, Week 4, Week 8, Week 12, Week 16

  9. Vital Signs

    Change in Vital Signs (including Heart Rate, Blood Pressure, Body Weight, BMI)

    Time frame: Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Unscheduled Safety Visit

  10. Metabolic Function

    Change in Metabolic Function Test Results of Lipids, Glucose, Hemoglobin A1c (HbA1c)

    Time frame: Baseline, Week 12

  11. Clinical Safety Laboratory Values

    Change in Clinical Safety Laboratory Values (biochemistry, hematology, urine examination)

    Time frame: Screening, Baseline, Week 4, Week 8, Week 12, Week 16

  12. AEs

    Incidence of Adverse Events (AEs)

    Time frame: Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Ad Hoc

  13. ECG

    Change in Electrocardiogram (ECG) Values

    Time frame: Screening, Baseline, Week 4, Week 8, Week 12, Week 16

  14. CSSRS

    Change in Scores of Columbia Suicide Severity Rating Scale (CSSRS)

    Time frame: Screening, Week 4, Week 8, Week 12, Week 16

07

Results

Posted May 6, 2021

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.

Participant flow — Overall Study
MilestoneXanamem™Placebo
Started9194
Completed8289
Not completed95
Withdrew: Adverse event20
Withdrew: Withdrawal by subject53
Withdrew: Protocol violation01
Withdrew: Physician decision01
Withdrew: Lost to follow-up10
Withdrew: Sponsor decision10

Outcome measures

PrimaryADAS-Cog v14

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.

Time frame:
Baseline, Week 12
Reported as:
Mean · units on a scale
ADAS-Cog v14
units on a scaleXanamem™Placebo
ADAS-Cog v14-1.5 ± 6.47-0.7 ± 6.65
PrimaryAD COMposite Scores

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.

Time frame:
Baseline, Week 12
Reported as:
Mean · score on a scale
AD COMposite Scores
score on a scaleXanamem™Placebo
AD COMposite Scores0.02472 ± 0.1441350.01908 ± 0.151502
SecondaryRAVLT

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.

Time frame:
Baseline, Week 12
Reported as:
Mean · score on a scale
RAVLT
score on a scaleXanamem™Placebo
Recall List A - Total number of correct words0.3 ± 6.540.4 ± 6.31
Recall List B - Number of correct words0.3 ± 1.630.1 ± 1.30
Final recall of List A - Number of correct words0.2 ± 3.140.4 ± 2.40
SecondaryCDR-SOB

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.

Time frame:
Baseline, Week 12
Reported as:
Mean · score on a scale
CDR-SOB
score on a scaleXanamem™Placebo
CDR-SOB0.25 ± 1.2760.16 ± 1.325
SecondaryMMSE

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.

Time frame:
Baseline, Week 12
Reported as:
Mean · score on a scale
MMSE
score on a scaleXanamem™Placebo
MMSE0.2 ± 3.09-0.2 ± 2.85
SecondaryNPI (Neuropsychiatric Inventory)

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.

Time frame:
Baseline, Week 12
Reported as:
Mean · units on a scale
NPI (Neuropsychiatric Inventory)
units on a scaleXanamem™Placebo
NPI Total Score0.9 ± 8.670.8 ± 9.09
Delusions0.0 ± 0.380.1 ± 0.87
Hallucinations0.1 ± 0.600.0 ± 0.36
Agitation/Aggression0.2 ± 2.020.2 ± 1.91
Depression/Dysphoria0.0 ± 1.340.0 ± 1.91
Anxiety0.1 ± 1.70-0.4 ± 2.08
Elation/Euphoria0.1 ± 0.920.0 ± 0.67
Apathy/Indifference0.0 ± 2.180.3 ± 2.11
Disinhibition0.1 ± 1.150.1 ± 1.03
Irritability/Lability0.1 ± 1.940.5 ± 2.17
Aberrant Motor Behavior-0.1 ± 2.980.2 ± 2.37
Sleep0.2 ± 2.470.0 ± 1.83
Appetite and Eating Disorders0.1 ± 3.18-0.1 ± 2.02
SecondaryNTB - Executive Domain

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.

Time frame:
Baseline, Week 12
Reported as:
Mean · score on a scale
NTB - Executive Domain
score on a scaleXanamem™Placebo
COWAT Total Correct Words0.5 ± 8.080.5 ± 8.12
CTF Total Correct Responses0.3 ± 8.53-0.7 ± 6.28
NTB Total Score0.8 ± 11.50-0.2 ± 9.84
Other pre-specifiedPregnancy Test

Women of childbearing potential only. Serum pregnancy test at screening and a urine pregnancy test at all subsequent clinic visits

Time frame:
Screening, baseline, Week 4, Week, 8, Week 12, Week 16

Results for this outcome have not been posted.

Other pre-specifiedOptional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Testosterone

This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit

Time frame:
Screening, baseline, Week 4, Week, 8, Week 12, Week 16

Results for this outcome have not been posted.

Other pre-specifiedOptional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Androstenedione

This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit

Time frame:
Screening, baseline, Week 4, Week, 8, Week 12, Week 16

Results for this outcome have not been posted.

Other pre-specifiedOptional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Dehydroepiandrosterone Sulfate (DHEAS)

This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit

Time frame:
Screening, baseline, Week 4, Week, 8, Week 12, Week 16

Results for this outcome have not been posted.

Other pre-specifiedOptional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Adrenocorticotropic Hormone (ACTH)

This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit

Time frame:
Screening, baseline, Week 4, Week, 8, Week 12, Week 16

Results for this outcome have not been posted.

Other pre-specifiedChange in Pharmacokinetics (PK), Including Analysis of Cortisol Levels

This assessment will be carried out on subjects who consented to this optional test. PD sample will be collected at pre-dose at each required visit

Time frame:
Baseline, Week 4, Week 8, Week 12 and Unscheduled Safety Visit

Results for this outcome have not been posted.

Other pre-specifiedNTSS-6

Change in Neuropathy Total Symptom Score (NTSS-6)

Time frame:
Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Ad Hoc and Unscheduled Safety Visit

Results for this outcome have not been posted.

Other pre-specifiedNFM

Change in Nerve Function Monitoring (NFM)

Time frame:
Screening, Baseline, Week 4, Week 8, Week 12, Week 16

Results for this outcome have not been posted.

Other pre-specifiedVital Signs

Change in Vital Signs (including Heart Rate, Blood Pressure, Body Weight, BMI)

Time frame:
Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Unscheduled Safety Visit

Results for this outcome have not been posted.

Other pre-specifiedMetabolic Function

Change in Metabolic Function Test Results of Lipids, Glucose, Hemoglobin A1c (HbA1c)

Time frame:
Baseline, Week 12

Results for this outcome have not been posted.

Other pre-specifiedClinical Safety Laboratory Values

Change in Clinical Safety Laboratory Values (biochemistry, hematology, urine examination)

Time frame:
Screening, Baseline, Week 4, Week 8, Week 12, Week 16

Results for this outcome have not been posted.

Other pre-specifiedAEs

Incidence of Adverse Events (AEs)

Time frame:
Screening, Baseline, Week 4, Week 8, Week 12, Week 16, Ad Hoc

Results for this outcome have not been posted.

Other pre-specifiedECG

Change in Electrocardiogram (ECG) Values

Time frame:
Screening, Baseline, Week 4, Week 8, Week 12, Week 16

Results for this outcome have not been posted.

Other pre-specifiedCSSRS

Change in Scores of Columbia Suicide Severity Rating Scale (CSSRS)

Time frame:
Screening, Week 4, Week 8, Week 12, Week 16

Results for this outcome have not been posted.

Adverse events

Collected over 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.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Xanamem™0/91 (0%)4/91 (4.4%)33/91 (36.3%)
Placebo0/94 (0%)4/94 (4.3%)32/94 (34%)
Most frequent serious events
Most frequent serious events
EventXanamem™Placebo
PneumoniaInfections and infestations2/910/94
Vibration test abnormalInvestigations1/910/94
Musculoskeletal Chest PainMusculoskeletal and connective tissue disorders1/910/94
Pulmonary CavitationRespiratory, thoracic and mediastinal disorders1/910/94
Acute myocardial infarctionCardiac disorders0/911/94
InfluenzaInfections and infestations0/911/94
FallInjury, poisoning and procedural complications0/911/94
Rib FractureInjury, poisoning and procedural complications0/911/94
Transient Ischaemic AttackNervous system disorders0/911/94
Most frequent other events
Most frequent other events
EventXanamem™Placebo
HeadacheNervous system disorders9/9110/94
DizzinessNervous system disorders8/914/94
Urinary tract infectionInfections and infestations6/912/94
DiarrhoeaGastrointestinal disorders6/915/94
FallInjury, poisoning and procedural complications3/916/94
Pain in extremityMusculoskeletal and connective tissue disorders1/915/94

Baseline characteristics

The FAS comprised all subjects randomised who received at least one dose of study drug and had at least one valid post-baseline measurement where changes from Baseline were analysed. Demographic data and subject characteristics at Baseline were summarised overall and by treatment, group using descriptive summary statistics for the Full Analysis Set (FAS) to include: age, gender and race. Baseline characteristic results of height, weight, BMI were also summarised overall and by treatment group.

Age, Categorical
Age, Categorical(Participants)Xanamem™PlaceboTotal
<=18 years000
Between 18 and 65 years192443
>=65 years7270142
Age, Continuous
Age, Continuous(years)Xanamem™PlaceboTotal
Median71.3 ± 8.7170.8 ± 8.2071.0 ± 8.43
Sex: Female, Male
Sex: Female, Male(Participants)Xanamem™PlaceboTotal
Female5254106
Male394079
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Xanamem™PlaceboTotal
American Indian or Alaska Native000
Asian437
Native Hawaiian or Other Pacific Islander000
Black or African American171330
White6574139
More than one raceNANANA
Unknown or Not Reported022
Region of Enrollment
Region of Enrollment(participants)Xanamem™PlaceboTotal
United States5355108
United Kingdom141529
Australia242448
Height
Height(centimetres (cm))Xanamem™PlaceboTotal
Mean165.49 ± 9.665166.36 ± 8.964165.94 ± 9.295
Body Mass Index (BMI)
Body Mass Index (BMI)(kilogram / square meter (kg/m^2))Xanamem™PlaceboTotal
Mean27.31 ± 5.02427.08 ± 6.57027.19 ± 5.855
Weight
Weight(kilogram (kg))Xanamem™PlaceboTotal
Mean74.90 ± 15.96474.88 ± 18.77474.89 ± 17.424
08

Study locations

25 sites
  • Tucson Neuroscience Research, LLC
    Tucson, Arizona 85710, United States
  • National Research Institute
    Los Angeles, California 90057, United States
  • PCND Neuroscience Research Institute
    Poway, California 92064, United States
  • Pacific Research Network, Inc.
    San Diego, California 92103, United States
  • Research Alliance Inc.
    Clearwater, Florida 33756, United States
  • The Neurology Research Group, LLC
    Miami, Florida 33186, United States
  • Compass Research LLC
    Orlando, Florida 32806, United States
  • IMIC, Inc.
    Palmetto Bay, Florida 33157, United States
  • Atlanta Center for Medical Research
    Atlanta, Georgia 30331, United States
  • NeuroStudies.Net, LLC
    Decatur, Georgia 30033, United States
  • The NeuroCognitive Institute
    Mount Arlington, New Jersey 07856, United States
  • Richmond Behavioral Associates
    Staten Island, New York 10312, United States
  • PMG Research of Rocky Mount, LLC
    Rocky Mount, North Carolina 27804, United States
  • The Clinical Trial Center
    Jenkintown, Pennsylvania 19046, United States
  • Central Coast Neurosciences Research
    Central Coast, New South Wales 2261, Australia
  • St Vincent's Hospital Sydney
    Darlinghurst, New South Wales 2010, Australia
  • KaRa Institute of Neurological Diseases
    Macquarie Park, New South Wales 2113, Australia
  • Medical & Cognitive Research Unit, Heidelberg Repatriation Hospital - Austin Health
    Heidelberg West, Victoria 3081, Australia
  • Australian Alzheimer's Research Foundation
    Nedlands, Western Australia 6009, Australia
  • The Research Institute for the Care of Older People
    Bath, Combe Park BA1 3NG, United Kingdom
  • Manchester Mental Health & Social Care Trust - Dementia Research Office - Park House North Manchester General Hospital
    Manchester, Lancashire M8 5RB, United Kingdom
  • West London Mental Health Trust
    Isleworth, London TW7 6FY, United Kingdom
  • St Pancras Clinical Research
    Kings Cross, London WC1X 8QD, United Kingdom
  • Institute of Clinical Sciences, Queen's University Belfast
    Belfast, Northern Ireland BT9 7AB, United Kingdom
  • Centre for Clinical Brain Sciences, Centre for Dementia Prevention, The University of Edinburgh
    Edinburgh, EH8 9YL, United Kingdom
09

References and documents

Publications

  • Webster SP, McBride A, Binnie M, Sooy K, Seckl JR, Andrew R, Pallin TD, Hunt HJ, Perrior TR, Ruffles VS, Ketelbey JW, Boyd A, Walker BR. Selection and early clinical evaluation of the brain-penetrant 11beta-hydroxysteroid dehydrogenase type 1 (11beta-HSD1) inhibitor UE2343 (Xanamem). Br J Pharmacol. 2017 Mar;174(5):396-408. doi: 10.1111/bph.13699. Epub 2017 Jan 25. PubMed 28012176 ↗

Study documents

  • Study protocol · Jul 18, 2018
  • Statistical analysis plan · Mar 22, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02727699
Lead sponsor
Actinogen Medical
Collaborators
ICON Clinical Research
Responsible party
Sponsor
First posted
Apr 5, 2016
Start date
Mar 23, 2017
Primary completion
Mar 15, 2019
Completion
Mar 15, 2019
Results posted
May 6, 2021
Last update
Feb 3, 2025

Study contacts

Bill Ketelbey, MD
study chair · Actinogen Medical
Alan Boyd, MD, FFPM
study director · Actinogen Medical

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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