Trial · NCT02727699

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

NCT02727699, Phase 2, Completed, Actinogen Medical; results first posted 2021-05-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu). Trials, record NCT02727699. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02727699

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu)
NCT number: NCT02727699
Status: Completed
Phases: Phase 2
Enrollment: 185 participants, actual
Lead sponsor: Actinogen Medical
Conditions: Dementia, Alzheimer Type
Interventions: Xanamem™, Placebo (for Xanamem™)
First posted: 2016-04-05
Last updated: 2025-02-03
Results first posted: 2021-05-06

Source ClinicalTrials.gov

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	ADAS-Cog v14	Baseline, Week 12	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.
Primary	AD COMposite Scores	Baseline, Week 12	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.
Secondary	RAVLT	Baseline, Week 12	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.
Secondary	CDR-SOB	Baseline, Week 12	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.
Secondary	MMSE	Baseline, Week 12	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.
Secondary	NPI (Neuropsychiatric Inventory)	Baseline, Week 12	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.
Secondary	NTB - Executive Domain	Baseline, Week 12	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.
Other	Pregnancy Test	Screening, baseline, Week 4, Week, 8, Week 12, Week 16	Women of childbearing potential only. Serum pregnancy test at screening and a urine pregnancy test at all subsequent clinic visits
Other	Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Testosterone	Screening, baseline, Week 4, Week, 8, Week 12, Week 16	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
Other	Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Androstenedione	Screening, baseline, Week 4, Week, 8, Week 12, Week 16	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

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes21

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	ADAS-Cog v14	Baseline, Week 12	The ADAS-cog v14 includes the following 14 items, with a Total scoring range of 0 - 90. Higher scores indicate greater disease severity	units on a scale	MEAN
PRIMARY	AD COMposite Scores	Baseline, Week 12	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).	score on a scale	MEAN
SECONDARY	RAVLT	Baseline, Week 12	Analysis of Change from Baseline to Week 12/EOT in RAVLT from the Full Analysis Set (FAS).	score on a scale	MEAN
SECONDARY	CDR-SOB	Baseline, Week 12	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.	score on a scale	MEAN
SECONDARY	MMSE	Baseline, Week 12	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.	score on a scale	MEAN
SECONDARY	NPI (Neuropsychiatric Inventory)	Baseline, Week 12	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.	units on a scale	MEAN
SECONDARY	NTB - Executive Domain	Baseline, Week 12	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.	score on a scale	MEAN
OTHER_PRE_SPECIFIED	Pregnancy Test	Screening, baseline, Week 4, Week, 8, Week 12, Week 16
OTHER_PRE_SPECIFIED	Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Testosterone	Screening, baseline, Week 4, Week, 8, Week 12, Week 16
OTHER_PRE_SPECIFIED	Optional PD Assessment - Changes in Pharmacodynamic (PD) Measures of Androstenedione	Screening, baseline, Week 4, Week, 8, Week 12, Week 16

1 to 10 of 21Source ClinicalTrials.gov

See all 21 outcomes

Results by group46

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
ADAS-Cog v14	Xanamem™		-1.5	Standard Deviation 6.47	units on a scale
ADAS-Cog v14	Placebo		-0.7	Standard Deviation 6.65	units on a scale
AD COMposite Scores	Xanamem™		0.02472	Standard Deviation 0.144135	score on a scale
AD COMposite Scores	Placebo		0.01908	Standard Deviation 0.151502	score on a scale
RAVLT	Xanamem™	Recall List A - Total number of correct words	0.3	Standard Deviation 6.54	score on a scale
RAVLT	Placebo	Recall List A - Total number of correct words	0.4	Standard Deviation 6.31	score on a scale
RAVLT	Xanamem™	Recall List B - Number of correct words	0.3	Standard Deviation 1.63	score on a scale
RAVLT	Placebo	Recall List B - Number of correct words	0.1	Standard Deviation 1.30	score on a scale
RAVLT	Xanamem™	Final recall of List A - Number of correct words	0.2	Standard Deviation 3.14	score on a scale
RAVLT	Placebo	Final recall of List A - Number of correct words	0.4	Standard Deviation 2.40	score on a scale

1 to 10 of 46Source ClinicalTrials.gov

See all 46 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Xanamem™	91
Overall Study	STARTED	Placebo	94
Overall Study	COMPLETED	Xanamem™	82
Overall Study	COMPLETED	Placebo	89
Overall Study	NOT COMPLETED	Xanamem™	9
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Headache	Nervous system disorders	Xanamem™	9	91
other	Headache	Nervous system disorders	Placebo	10	94
other	Urinary tract infection	Infections and infestations	Xanamem™	6	91
other	Urinary tract infection	Infections and infestations	Placebo	2	94
other	Pain in extremity	Musculoskeletal and connective tissue disorders	Xanamem™	1	91
other	Pain in extremity	Musculoskeletal and connective tissue disorders	Placebo	5	94
other	Diarrhoea	Gastrointestinal disorders	Xanamem™	6	91
other	Diarrhoea	Gastrointestinal disorders	Placebo	5	94
other	Fall	Injury, poisoning and procedural complications	Xanamem™	3	91
other	Fall	Injury, poisoning and procedural complications	Placebo	6	94

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Xanamem™	0	91
Total, all-cause mortality	Placebo	0	94
Total, other adverse events	Xanamem™	33	91
Total, other adverse events	Placebo	32	94
Total, serious adverse events	Xanamem™	4	91
Total, serious adverse events	Placebo	4	94

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28012176	BACKGROUND	PubMed
38848180	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Xanamem™ vs Placebo: deaths from any cause	Trial comparisons
Xanamem™ vs Placebo: serious adverse events	Trial comparisons

Tests2

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as	Source
Verbal Fluency	Secondary outcome	ConductCognition
Verbal Learning	Secondary outcome	ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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