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A Phase II Study to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects With Mild Dementia Due to AD (XanADu)
Phase 2 trial testing Xanamem™ in Dementia, Alzheimer Type in 185 participants. Completed in 15 March 2019.
| Lead sponsor | Actinogen Medical |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 185 |
| Start date | 23 March 2017 |
| Primary completion | 15 March 2019 |
| Estimated completion | 15 March 2019 |
| Sites | 25 locations across United Kingdom, United States, Australia |
Actinogen Medical — full company profile →
50 and older, any sex, with Dementia, Alzheimer Type. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | -1.5 | ± 6.47 |
| Placebo | -0.7 | ± 6.65 |
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
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.02472 | ± 0.144135 |
| Placebo | 0.01908 | ± 0.151502 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.3 | ± 6.54 |
| Placebo | 0.4 | ± 6.31 |
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.3 | ± 1.63 |
| Placebo | 0.1 | ± 1.30 |
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.2 | ± 3.14 |
| Placebo | 0.4 | ± 2.40 |
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
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.25 | ± 1.276 |
| Placebo | 0.16 | ± 1.325 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.2 | ± 3.09 |
| Placebo | -0.2 | ± 2.85 |
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 dyspho
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.9 | ± 8.67 |
| Placebo | 0.8 | ± 9.09 |
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.0 | ± 0.38 |
| Placebo | 0.1 | ± 0.87 |
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.1 | ± 0.60 |
| Placebo | 0.0 | ± 0.36 |
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.2 | ± 2.02 |
| Placebo | 0.2 | ± 1.91 |
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.0 | ± 1.34 |
| Placebo | 0.0 | ± 1.91 |
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.1 | ± 1.70 |
| Placebo | -0.4 | ± 2.08 |
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.1 | ± 0.92 |
| Placebo | 0.0 | ± 0.67 |
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.0 | ± 2.18 |
| Placebo | 0.3 | ± 2.11 |
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 po
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.5 | ± 8.08 |
| Placebo | 0.5 | ± 8.12 |
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.3 | ± 8.53 |
| Placebo | -0.7 | ± 6.28 |
| Group | Value | 95% CI |
|---|---|---|
| Xanamem™ | 0.8 | ± 11.50 |
| Placebo | -0.2 | ± 9.84 |
Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Xanamem™ | Placebo |
|---|---|---|---|
| Pneumonia | Infections and infestations | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — |
| Influenza | Infections and infestations | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Rib Fracture | Injury, poisoning and procedural complications | — | — |
| Vibration test abnormal | Investigations | — | — |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | — | — |
| Transient Ischaemic Attack | Nervous system disorders | — | — |
| Pulmonary Cavitation | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Xanamem™ | Placebo |
|---|---|---|---|
| Headache | Nervous system disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
Most-reported serious reactions: Pneumonia, Acute myocardial infarction, Influenza, Fall, Rib Fracture, Vibration test abnormal, Musculoskeletal Chest Pain, Transient Ischaemic Attack.
Data from ClinicalTrials.gov NCT02727699 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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