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The goal of this Phase 2 Alzheimer's study is to determine whether 1.0 mg/kg XPro1595 confers a benefit on cognition, function, and biomarkers of white matter and to further evaluate safety and tolerability. The objectives of this study are to determine the safety, tolerability, and efficacy of XPro1595 in patients with early ADi.
This trial is a randomized clinical study using XPro1595 to treat patients with Early Alzheimer's Disease with biomarkers of inflammation (ADi). Early ADi patients are defined as patients with Mild Alzheimer's Disease or Mild Cognitive Impairment (MCI) with a biomarker of inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.0 mg/kg XPro1595 | Experimental | 1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks. |
|
| 1.0 mg/kg Placebo | Placebo Comparator | 1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XPro1595 | Drug | XPro1595 will be delivered by subcutaneous injection once a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Early and Mild Alzheimer's Cognitive Composite (EMACC) | Change from Baseline to Week 24 in the Early and Mild Alzheimer's Cognitive Composite (EMACC), a z-score composite of six neuropsychological tests (International Shopping List Test-Immediate Recall; Digit Span Forward/Backward; Category Fluency; Letter Fluency [D-KEFS]; Trail Making Test A and B; Digit Symbol Coding). Each component is standardized to the pooled baseline mean (0) and SD (1), then averaged. Higher scores indicate better cognitive performance; a positive change from baseline indicates improvement. | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CDR-SB | Change from Baseline to Week 24 in the Clinical Dementia Rating - Sum of Boxes (CDR-SB), the sum of the six CDR domain box scores (each 0, 0.5, 1, 2, or 3); total range 0 to 18, with higher scores indicating greater impairment (worse outcome). A negative change favors XPro1595 (less decline). | 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Goal Attainment Scale (GAS) | Goal Attainment Scaling (GAS): an individualized outcome in which each participant set a minimum of three personalized treatment goals at baseline. Attainment of each goal is rated on a 5-point scale (-2 = much worse than expected; -1 = baseline/somewhat worse; 0 = expected goal level; +1 = somewhat better; +2 = much better than expected). A participant's goal ratings are aggregated across goals into a standardized GAS T-score using the Kiresuk-Sherman formula (which accounts for the number of goals and their inter-correlation), scaled to a mean of 50 and a standard deviation of 10. The reported values are the standardized GAS T-score, not the individual -2 to +2 ratings; a T-score of 50 indicates goals were met on average, and higher T-scores indicate greater goal attainment (better outcome). |
The screening window for this trial is 45 days.
Inclusion Criteria:
To be eligible for study entry, patients must satisfy all of the following criteria:
Exclusion Criteria:
Patients will be excluded from the study if 1 or more of the following criteria are applicable:
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| Name | Affiliation | Role |
|---|---|---|
| Therese Blomberg | INmune Bio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INmune Bio Investigational Site | Darlinghurst | New South Wales | 2010 | Australia | ||
| INmune Bio Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16705109 | Background | Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006 May 17;295(19):2275-85. doi: 10.1001/jama.295.19.2275. | |
| 21239393 |
| Label | URL |
|---|---|
| Alzheimer's Association annual report releasing statistics regarding Alzheimer's disease | View source |
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Of 721 screened, 514 did not meet eligibility. Criteria: MCI or mild AD dementia (McKhann; CDR global 0.5-1.0), age 50-85, MMSE ≥22, amyloid positivity (with protocol-amendment flexibility during operational constraints), and ≥1 of 4 inflammatory biomarkers (hsCRP >1.5 mg/L, ESR >10 mm/h, HbA1C >6.0 DCCT%, or ≥1 APOE4 allele). 207 were randomized 2:1 to XPro1595 or placebo, stratified by clinical stage (MCI vs. mild AD) and sex. One randomized participant did not receive study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1.0 mg/kg XPro1595 | 1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks. XPro1595: XPro1595 will be delivered by subcutaneous injection once a week |
| FG001 | 1.0 mg/kg Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 13, 2024 |
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| Placebo | Drug | Placebo will be delivered by subcutaneous injection once a week |
|
|
| Change in Everyday Cognition (E-Cog) |
Change from Baseline to Week 24 in the Everyday Cognition (E-Cog) total score, a 39-item informant-report questionnaire that asks the study partner to rate the participant's current performance on cognitively relevant everyday activities relative to 10 years prior (i.e., before illness onset). Activities span memory, language, visuospatial/perceptual abilities, planning, organization, and divided attention. Each item is rated on a 4-point scale from 1 (better or no change) to 4 (consistently much worse). The total score is the mean of all rated items and ranges from 1 to 4, with higher scores indicating greater decline since prior to illness onset. |
| 24 Weeks |
| Change in Neuropsychiatric Inventory (NPI-12) Total Score at Week 24 | Change from Baseline to Week 24 in the Neuropsychiatric Inventory, 12-domain version (NPI-12), a structured interview administered to the study partner (informant) assessing 12 neuropsychiatric domains (delusions; hallucinations; agitation/aggression; depression/dysphoria; anxiety; elation/euphoria; apathy/indifference; disinhibition; irritability/lability; aberrant motor behavior; nighttime behaviors; appetite/eating). Each domain is scored as frequency (1-4) × severity (1-3); the total score is the sum of domain scores and ranges from 0 to 144. Higher scores indicate greater neuropsychiatric burden (worse outcome); a negative change from baseline favors XPro1595. The total score is reported; domain or subfactor scores, where applicable, are interpreted only within the context of the full instrument. | 24 Weeks |
| 24 Weeks |
| Macquarie Park |
| New South Wales |
| 2113 |
| Australia |
| INmune Bio Investigational Site | Adelaide | South Australia | 5011 | Australia |
| INmune Bio Investigational Site | Box Hill | Victoria | 3128 | Australia |
| INmune Bio Investigational Site | Carlton | Victoria | 3053 | Australia |
| INmune Bio Investigational Site | Ivanhoe | Victoria | 3079 | Australia |
| INmune Bio Investigational Site | Parkville | Victoria | 3050 | Australia |
| INmune Bio Investigational Site | Nedlands | Western Australia | 6009 | Australia |
| INmune Bio Investigational Site | Kelowna | V1Y 1Z9 | Canada |
| INmune Bio Investigational Site | Ottawa | K1Z 1G3 | Canada |
| INmune Bio Investigational Site | Sherbrooke | J1L 0H8 | Canada |
| INmune Bio Investigational Site | Toronto | M3B 2S7 | Canada |
| INmune Bio Investigational Site | Toronto | M4G 3E8 | Canada |
| INmune Bio Investigational Site | West Vancouver | V7T 1C5 | Canada |
| INmune Bio Investigational Site | Brno | 60200 | Czechia |
| INmune Bio Investigational Site | Pilsen | 30100 | Czechia |
| INmune Bio Investigational Site | Prague | 10000 | Czechia |
| INmune Bio Investigational Site | Prague | 16000 | Czechia |
| INmune Bio Investigational Site | Rychnov nad Kněžnou | 51601 | Czechia |
| INmune Bio Investigational Site | Bron | 69500 | France |
| INmune Bio Investigational Site | Nantes | 44800 | France |
| INmune Bio Investigational Site | Toulouse | 31059 | France |
| INmune Bio Investigational Site | Berlin | 10629 | Germany |
| INmune Bio Investigational Site | Chemnitz | 09111 | Germany |
| INmune Bio Investigational Site | Bialystok | 15-756 | Poland |
| INmune Bio Investigational Site | Bydgoszcz | 85-133 | Poland |
| INmune Bio Investigational Site | Wroclaw | 53-659 | Poland |
| INmune Bio Investigational Site | Barcelona | 08028 | Spain |
| INmune Bio Investigational Site | Barcelona | 08222 | Spain |
| INmune Bio Investigational Site | Córdoba | 14004 | Spain |
| INmune Bio Investigational Site | Madrid | 28006 | Spain |
| INmune Bio Investigational Site | Seville | 41009 | Spain |
| INmune Bio Investigational Site | Valencia | 46017 | Spain |
| INmune Bio Investigational Site | Valencia | 46026 | Spain |
| INmune Bio Investigational Site | Birmingham | B16 8LT | United Kingdom |
| INmune Bio Investigational Site | Bristol | BS32 4SY | United Kingdom |
| INmune Bio Investigational Site | Guildford | GU2 7YD | United Kingdom |
| INmune Bio Investigational Site | London | W1G 9JF | United Kingdom |
| INmune Bio Investigational Site | Motherwell | ML1 4UF | United Kingdom |
| INmune Bio Investigational Site | Plymouth | PL7 8BT | United Kingdom |
| INmune Bio Investigational Site | Winchester | S021 1HU | United Kingdom |
| Chance SA, Clover L, Cousijn H, Currah L, Pettingill R, Esiri MM. Microanatomical correlates of cognitive ability and decline: normal ageing, MCI, and Alzheimer's disease. Cereb Cortex. 2011 Aug;21(8):1870-8. doi: 10.1093/cercor/bhq264. Epub 2011 Jan 14. |
| 27470609 | Background | Chou RC, Kane M, Ghimire S, Gautam S, Gui J. Treatment for Rheumatoid Arthritis and Risk of Alzheimer's Disease: A Nested Case-Control Analysis. CNS Drugs. 2016 Nov;30(11):1111-1120. doi: 10.1007/s40263-016-0374-z. |
| 22966039 | Background | Clark I, Atwood C, Bowen R, Paz-Filho G, Vissel B. Tumor necrosis factor-induced cerebral insulin resistance in Alzheimer's disease links numerous treatment rationales. Pharmacol Rev. 2012 Oct;64(4):1004-26. doi: 10.1124/pr.112.005850. Epub 2012 Sep 10. |
1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks.
Placebo: Placebo will be delivered by subcutaneous injection once a week
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline characteristics are reported for the modified Intent-to-Treat (mITT) population: all randomized participants who received ≥1 dose of study drug and had ≥1 post-baseline efficacy assessment. The mITT excludes 1 randomized participant who did not receive study drug and 6 dosed participants without post-baseline efficacy data.
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| ID | Title | Description |
|---|---|---|
| BG000 | 1.0 mg/kg XPro1595 | 1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks. XPro1595: XPro1595 will be delivered by subcutaneous injection once a week |
| BG001 | 1.0 mg/kg Placebo | 1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks. Placebo: Placebo will be delivered by subcutaneous injection once a week |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Diagnosis | Count of Participants | Participants |
| ||||||||||||||||||
| Clinical Dementia Rating (CDR) Global Score | Clinical Dementia Rating (CDR) Global Score: a clinician-rated dementia staging instrument assessing six domains (memory; orientation; judgment and problem-solving; community affairs; home and hobbies; personal care). The Global Score is derived from the domain ratings by standard CDR scoring rules and takes the values 0 (no dementia), 0.5 (questionable), 1 (mild), 2 (moderate), and 3 (severe). Higher scores indicate greater dementia severity (worse outcome). Consistent with the MCI / mild-AD enrollment criteria, participants were staged CDR 0.5 or 1.0 at baseline. | Count of Participants | Participants |
| |||||||||||||||||
| Clinical Dementia Rating - Sum of Boxes (CDR-SB) | Clinical Dementia Rating - Sum of Boxes (CDR-SB): the sum of the six CDR domain box scores (memory; orientation; judgment and problem-solving; community affairs; home and hobbies; personal care), each rated 0, 0.5, 1, 2, or 3. The total (sum of boxes) ranges from 0 to 18; higher scores indicate greater impairment (worse outcome). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Mini-Mental State Examination (MMSE) | Mini-Mental State Examination (MMSE): a clinician-administered global cognitive screening instrument. The total score ranges from 0 to 30; higher scores indicate better cognitive function (better outcome). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Early and Mild Alzheimer's Cognitive Composite (EMACC) | Early and Mild Alzheimer's Cognitive Composite (EMACC): a z-score composite of six neuropsychological tests (International Shopping List Test-Immediate Recall; Digit Span Forward/Backward; Category Fluency; Letter Fluency [D-KEFS]; Trail Making Test A and B; Digit Symbol Coding). Each component is standardized to the pooled baseline mean (0) and SD (1), then averaged; higher scores indicate better performance. The baseline composite mean is 0 by construction (an artifact of standardization), not a data entry error. | Mean | Standard Deviation | z-score |
| ||||||||||||||||
| APOE E4 status | APOE ε4 status was determined by genotyping. Participants were classified as noncarrier (no ε4 allele), heterozygote (one ε4 allele), or homozygote (two ε4 alleles). | Count of Participants | Participants |
| |||||||||||||||||
| Biologically confirmed amyloid positive | Amyloid positivity was required for eligibility, documented in medical history or confirmed at screening by a blood-based amyloid assay (with protocol-amendment flexibility permitting enrollment without amyloid confirmation when timely testing was unavailable). The category reflects available confirmatory amyloid status at baseline. | Count of Participants | Participants |
| |||||||||||||||||
| Number of enrichment inflammatory biomarkers | Count of the four prespecified screening biomarkers of inflammation met by the participant: high-sensitivity CRP > 1.5 mg/L; erythrocyte sedimentation rate (ESR) > 10 mm/h; HbA1c > 6.0%; and ≥ 1 APOE ε4 allele. Eligibility required at least one of the four. | Count of Participants | Participants |
| |||||||||||||||||
| Time since AD diagnosis | Mean | Standard Deviation | years |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Early and Mild Alzheimer's Cognitive Composite (EMACC) | Change from Baseline to Week 24 in the Early and Mild Alzheimer's Cognitive Composite (EMACC), a z-score composite of six neuropsychological tests (International Shopping List Test-Immediate Recall; Digit Span Forward/Backward; Category Fluency; Letter Fluency [D-KEFS]; Trail Making Test A and B; Digit Symbol Coding). Each component is standardized to the pooled baseline mean (0) and SD (1), then averaged. Higher scores indicate better cognitive performance; a positive change from baseline indicates improvement. | Modified Intent-to-Treat (mITT) population: all randomized participants who received ≥1 dose of study drug and had ≥1 post-baseline efficacy assessment (n=200). Week 24 MMRM included 169 participants with EMACC data (XPro1595 n=111, Placebo n=58). The mITT was the pre-specified primary analysis population per the Statistical Analysis Plan. | Posted | Least Squares Mean | Standard Error | z-score | 24 Weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change in CDR-SB | Change from Baseline to Week 24 in the Clinical Dementia Rating - Sum of Boxes (CDR-SB), the sum of the six CDR domain box scores (each 0, 0.5, 1, 2, or 3); total range 0 to 18, with higher scores indicating greater impairment (worse outcome). A negative change favors XPro1595 (less decline). | Modified Intent-to-Treat (mITT) population: all randomized participants who received ≥1 dose of study drug and had ≥1 post-baseline efficacy assessment (n=200). Week 24 MMRM included 179 participants with CDR-SB data (XPro1595 n=120, Placebo n=59). Analyzed per the Statistical Analysis Plan | Posted | Least Squares Mean | Standard Error | score on a scale | 24 Weeks |
|
| |||||||||||||||||||||||||||||
| Secondary | Change in Everyday Cognition (E-Cog) | Change from Baseline to Week 24 in the Everyday Cognition (E-Cog) total score, a 39-item informant-report questionnaire that asks the study partner to rate the participant's current performance on cognitively relevant everyday activities relative to 10 years prior (i.e., before illness onset). Activities span memory, language, visuospatial/perceptual abilities, planning, organization, and divided attention. Each item is rated on a 4-point scale from 1 (better or no change) to 4 (consistently much worse). The total score is the mean of all rated items and ranges from 1 to 4, with higher scores indicating greater decline since prior to illness onset. | Modified Intent-to-Treat (mITT) population: all randomized participants who received ≥1 dose of study drug and had ≥1 post-baseline efficacy assessment (n=200). Week 24 MMRM included 177 participants with E-Cog data (XPro1595 n=119, Placebo n=58). Analyzed per the Statistical Analysis Plan. | Posted | Least Squares Mean | Standard Error | score on a scale | 24 Weeks |
| ||||||||||||||||||||||||||||||
| Secondary | Change in Neuropsychiatric Inventory (NPI-12) Total Score at Week 24 | Change from Baseline to Week 24 in the Neuropsychiatric Inventory, 12-domain version (NPI-12), a structured interview administered to the study partner (informant) assessing 12 neuropsychiatric domains (delusions; hallucinations; agitation/aggression; depression/dysphoria; anxiety; elation/euphoria; apathy/indifference; disinhibition; irritability/lability; aberrant motor behavior; nighttime behaviors; appetite/eating). Each domain is scored as frequency (1-4) × severity (1-3); the total score is the sum of domain scores and ranges from 0 to 144. Higher scores indicate greater neuropsychiatric burden (worse outcome); a negative change from baseline favors XPro1595. The total score is reported; domain or subfactor scores, where applicable, are interpreted only within the context of the full instrument. | Modified Intent-to-Treat (mITT) population: all randomized participants who received ≥1 dose of study drug and had ≥1 post-baseline efficacy assessment (n=200). Week 24 MMRM included 179 participants with NPI-12 data (XPro1595 n=120, Placebo n=59). Analyzed per the Statistical Analysis Plan | Posted | Least Squares Mean | Standard Error | score on a scale | 24 Weeks |
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Change in Goal Attainment Scale (GAS) | Goal Attainment Scaling (GAS): an individualized outcome in which each participant set a minimum of three personalized treatment goals at baseline. Attainment of each goal is rated on a 5-point scale (-2 = much worse than expected; -1 = baseline/somewhat worse; 0 = expected goal level; +1 = somewhat better; +2 = much better than expected). A participant's goal ratings are aggregated across goals into a standardized GAS T-score using the Kiresuk-Sherman formula (which accounts for the number of goals and their inter-correlation), scaled to a mean of 50 and a standard deviation of 10. The reported values are the standardized GAS T-score, not the individual -2 to +2 ratings; a T-score of 50 indicates goals were met on average, and higher T-scores indicate greater goal attainment (better outcome). | Modified Intent-to-Treat (mITT) population: all randomized participants who received ≥1 dose of study drug and had ≥1 post-baseline efficacy assessment as per the SAP | Posted | Least Squares Mean | Standard Error | score on a scale | 24 Weeks |
|
24 weeks of treatment plus 4 weeks of safety follow-up (28 weeks total)
TEAEs were events starting, or pre-existing conditions worsening, after the first dose. AEs were coded with MedDRA 28.0; severity and causality assessed by blinded investigators (Possibly/Probably/Related = treatment-related). An independent DMC reviewed unblinded safety data. AEs are reported for the Safety Analysis Set (received ≥1 dose: XPro1595 n=139, placebo n=67; total 206); one XPro1595-randomized participant (140 randomized) was not dosed. The mITT efficacy population was n=200.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1.0 mg/kg XPro1595 | 1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks. XPro1595: XPro1595 will be delivered by subcutaneous injection once a week | 0 | 139 | 8 | 139 | 131 | 139 |
| EG001 | 1.0 mg/kg Placebo | 1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks. Placebo: Placebo will be delivered by subcutaneous injection once a week | 0 | 67 | 5 | 67 | 59 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment | XPro1595 = 1/139, Placebo = 1/67 |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Strangulated hernia | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site cellulitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 28.0 | Systematic Assessment |
| |
| Hypergammaglobulinaemia benign monoclonal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site hypersensitivity | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site bruising | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 28.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP of Clinical Operations | INmune Bio, Inc. | 561-710-0512 | info@inmunebio.com |
| Jun 3, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D060825 | Cognitive Dysfunction |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C540591 | XENP 1595 |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Czechia |
|
| Poland |
|
| United Kingdom |
|
| Australia |
|
| France |
|
| Spain |
|
| Mild Alzheimer's Dementia (mAD) |
|
| 1.0 |
|
| Heterozygote (APOE ε3/ε4) |
|
| Homozygote (APOE ε4/ε4) |
|
| Unknown |
|
| Negative |
|
| Unknown |
|
| 2 Biomarker |
|
| 3 Biomarkers |
|
| 4 Biomarkers |
|
|
|
|
|
1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks.
Placebo: Placebo will be delivered by subcutaneous injection once a week
|
|
|
|