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| Name | Class |
|---|---|
| Grifols Biologicals, LLC | INDUSTRY |
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The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral and global domains based on the different applicable psychometric batteries and scales.
A clinical trial comprised of 350 subjects with probable mild to moderate Alzheimer's Disease (AD) will be conducted primarily to determine whether plasmapheresis with infusion of human albumin combined with intravenous immunoglobulin (IVIG) is able to modify patient's cognitive, functional, behavioral and global domains. There will be 3 treatment groups and 1 control group. The subjects will be randomized in a 1:1:1:1 proportion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Albumin + Immunoglobulin | Experimental | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period) |
|
| Low Albumin + Immunoglobulin | Experimental | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period) |
|
| Low Albumin | Experimental | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period) |
|
| Control (sham) group | No Intervention | Simulated plasma exchange procedure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albumin 5% | Biological | Therapeutic plasma exchange with human albumin 5% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score (Changes From Baseline to 14 Months) | ADAS-Cog total score as a change from baseline to 14 months The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment. | Baseline and 14 months |
| Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score (Changes From Baseline to 14 Months) | ADCS-ADL total score as a change from baseline to 14 months The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome). | Baseline and 14 Months |
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| Measure | Description | Time Frame |
|---|---|---|
| ADAS-Cog Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:22-26 | ADAS-Cog total score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):22-26 The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment. |
Main Inclusion Criteria:
Main Exclusion Criteria:
Any contraindication for plasma exchange due to behavioral disorders or abnormal coagulation parameters, such as for example:
Hemoglobin < 10 g/dL
Difficult venous access precluding plasma exchange.
A history of frequent adverse reactions (serious or otherwise) to blood products.
Hypersensitivity to albumin or allergies to any of the components of Albutein.
History of immunoglobulin A (IgA) deficiency.
Known allergies to Flebogamma DIF components such as sorbitol.
History of thromboembolic complications of intravenous immunoglobulins.
Plasma creatinine > 2 mg/dl.
Uncontrolled high blood pressure (systolic blood pressure of 160 mmHg or higher and/or diastolic blood pressure of 100 mmHg or higher despite treatment during the last 3 months).
Liver cirrhosis or any liver problem with glutamic pyruvic transaminase (GPT) > 2.5 x upper limit of normal (ULN), or bilirubin > 2 mg/dL.
Heart diseases, as evidenced by myocardial infarction, severe or unstable angina, or heart failure (New York Association Class II, III or IV) in the past 12 months.
Participation in other clinical trials, or the receipt of any other investigational drug in the three months prior to the start of the study.
Any condition complicating adherence to the study protocol (illness with less than one year of expected survival, known drug or alcohol abuse, etc.).
Pregnant or nursing women or women not using effective contraceptive methods for at least one month after plasma exchange.
Fewer than six years of education (exclusion criteria under medical criterion).
Less than three months with stable treatment for behavioral disorders or insomnia.
Patients being treated with anticoagulants or antiplatelet therapy (antiaggregants) should not be recruited in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Merce Boada Rovira, MD, PhD | Fundació ACE. Barcelona. Spain | Principal Investigator |
| Antonio Páez, MD | Instituto Grifols, S.A. | Study Chair |
| Laura Núñez, BSc | Instituto Grifols, S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northern California Research | Sacramento | California | 95821 | United States | ||
| Mountain View Clinical Research, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38489186 | Derived | Podger L, Stewart WF, Serrano D, Lipton RB, Gomez-Ulloa D, Ayasse ND, Barnes FB, Davis EA, Runken MC. Application of a Novel Endpoint Staging Framework: Proof of Concept in the AMBAR Study. J Alzheimers Dis. 2024;98(3):1079-1094. doi: 10.3233/JAD-231197. | |
| 35867135 | Derived | Cuberas-Borros G, Roca I, Castell-Conesa J, Nunez L, Boada M, Lopez OL, Grifols C, Barcelo M, Pareto D, Paez A. Neuroimaging analyses from a randomized, controlled study to evaluate plasma exchange with albumin replacement in mild-to-moderate Alzheimer's disease: additional results from the AMBAR study. Eur J Nucl Med Mol Imaging. 2022 Nov;49(13):4589-4600. doi: 10.1007/s00259-022-05915-5. Epub 2022 Jul 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Albumin + Immunoglobulin | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period) |
| FG001 | Low Albumin + Immunoglobulin |
| 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 | Yes | No | No | Study Protocol | Feb 21, 2018 | May 8, 2019 |
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|
| Albumin 20% | Biological | Low volume plasma exchange with human albumin 5% |
|
|
| Immunoglobulin | Biological | Intravenous human immunoglobulin 5% |
|
|
| Baseline and 14 months |
| ADCS-ADL Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:22-26 | ADCS-ADL total score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):22-26 The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome). | Baseline and 14 months |
| ADAS-Cog Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:18-21 | ADAS-Cog score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):18-21 The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment | Baseline and 14 months |
| ADCS-ADL Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:18-21 | ADCS-ADL total score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):18-21 The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome). | Baseline and 14 months |
| Denver |
| Colorado |
| 80209 |
| United States |
| Howard University | Washington D.C. | District of Columbia | 20059 | United States |
| Bradenton Research Center, Inc. | Bradenton | Florida | 34205 | United States |
| Quantum Laboratories | Deerfield Beach | Florida | 33064 | United States |
| Galiz Research, LLC | Hialeah | Florida | 33016 | United States |
| Largo Medical Center | Largo | Florida | 33770 | United States |
| L&L Research Choices, Inc | Miami | Florida | 33144 | United States |
| Allied Biomedical Research Institute | Miami | Florida | 33155 | United States |
| Miami Dade Medical Research Institute, LLC | Miami | Florida | 33176 | United States |
| Neurology Associates of Osmond Beach | Ormond Beach | Florida | 32174 | United States |
| PharmaSeek LLC (DMI Research) | Pinellas Park | Florida | 33782 | United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| RTR Medical Group | Savannah | Georgia | 31419 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| The NeuroCognitive Institute | Mount Arlington | New Jersey | 08756 | United States |
| Mid-Atlantic Geriatric/ARC | Paterson | New Jersey | 08759 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Neurology Specialists Inc | Dayton | Ohio | 45417 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Roper St. Francis Healthcare | Charleston | South Carolina | 29401 | United States |
| Wesley Neurology Clinic | Cordova | Tennessee | 38018 | United States |
| Hospital General de Elche | Elche | Alicante | 03203 | Spain |
| Hospital Universitario del Vinalopó | Elche | Alicante | 03293 | Spain |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital General de Catalunya | Sant Cugat del Vallès | Barcelona | 08190 | Spain |
| Hospital Universitari Mútua de Terrassa | Terrassa | Barcelona | 08221 | Spain |
| Hospital Universitario Nuestra Señora de Candelaria | Santa Cruz de Tenerife | Canary Islands | 38010 | Spain |
| Hospital Universitario de Getafe | Getafe | Madrid | 28905 | Spain |
| Fundació ACE | Barcelona | 08028 | Spain |
| Hospital Vall d'Hebrón | Barcelona | 08035 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario de Burgos | Burgos | 09005 | Spain |
| Parc Hospitalari Martí i Julià | Girona | 17190 | Spain |
| Hospital Universitari de Santa Maria | Lleida | 25198 | Spain |
| Hospital General Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Doctor Peset | Valencia | 46017 | Spain |
| Hospital Universitario y Politécnico La Fe | Valencia | 46026 | Spain |
| Hospital Viamed Montecanal | Zaragoza | 50012 | Spain |
Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period) |
| FG002 | Low Albumin | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period) |
| FG003 | Control (Sham) Group | Simulated plasma exchange procedure |
| Patients With Baseline MMSE:18-21 |
|
| Patients With Baseline MMSE:22-26 |
|
| Randomized Not Treated |
|
| Evaluable Subjects |
|
| COMPLETED |
|
| NOT COMPLETED |
|
322 evaluable subjects from analysis population were defined as the overall study population (N = 347) without 25 randomized no treated subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | High Albumin + Immunoglobulin | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period) |
| BG001 | Low Albumin + Immunoglobulin | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period) |
| BG002 | Low Albumin | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period) |
| BG003 | Control (Sham) Group | Simulated plasma exchange procedure |
| BG004 | 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 and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Baseline Mini-Mental State Examination total score | Mini-Mental State Examination (MMSE) is a widely used brief 30-point questionnaire test of cognitive function among the elderly; it includes tests of orientation, registration, attention and calculation, memory (recall, naming and repetition), language (comprehension, reading and writing) and visual-spatial skills. The score ranges from 0 to 30 and is obtained by summing the points corresponding to each answer. Lower score indicates more impaired cognition. | Mean | Standard Deviation | units on a scale |
|
| 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 | Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) Total Score (Changes From Baseline to 14 Months) | ADAS-Cog total score as a change from baseline to 14 months The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment. | Evaluable population with ADAS-Cog measurement at 14 months | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 14 months |
|
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Total Score (Changes From Baseline to 14 Months) | ADCS-ADL total score as a change from baseline to 14 months The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome). | Evaluable population with ADCS-ADL measurement at 14 months | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 14 Months |
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | ADAS-Cog Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:22-26 | ADAS-Cog total score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):22-26 The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment. | Evaluable population with baseline MMSE:22-26 and with ADAS-Cog measurement at 14 months | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 14 months |
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | ADCS-ADL Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:22-26 | ADCS-ADL total score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):22-26 The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome). | Evaluable population with baseline MMSE:22-26 and with ADCS-ADL measurement at 14 months | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 14 months |
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | ADAS-Cog Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:18-21 | ADAS-Cog score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):18-21 The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment | Evaluable population with baseline MMSE:18-21 and with ADAS-Cog measurement at 14 months | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 14 months |
| |||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | ADCS-ADL Total Score (Changes From Baseline to 14 Months) in Patients With Baseline MMSE:18-21 | ADCS-ADL total score as a change from baseline to 14 months in patients with baseline Mini-Mental State Examination (MMSE):18-21 The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome). | Evaluable population with baseline MMSE:18-21 and with ADCS-ADL measurement at 14 months | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 14 months |
|
14 Months
1 randomized subject in the control group was implanted by error with a real central catheter and was then transfered and treated as high albumin + immunoglobulin subject.
Therefore, this subject was considered for evaluable population as control (control group [n=80] and high albumin + immunoglobulin group [n=78]), but moved to high albumin + immunoglobulin group for safety analysis (control group [n=79] and high albumin + immunoglobulin group [n=79]).
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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 | High Albumin + Immunoglobulin | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period) | 0 | 79 | 16 | 79 | 67 | 79 |
| EG001 | Low Albumin + Immunoglobulin | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period) | 2 | 86 | 19 | 86 | 77 | 86 |
| EG002 | Low Albumin | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period) | 0 | 78 | 8 | 78 | 72 | 78 |
| EG003 | Control (Sham) Group | Simulated plasma exchange procedure | 0 | 79 | 8 | 79 | 56 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Intentional medical device removal by patient | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Thrombosis in device | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Device related sepsis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Endocarditis staphylococcal | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Anaesthetic complication cardiac | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Procedural intestinal perforation | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
| |
| Amyloid related imaging abnormalities | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Self injurious behaviour | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Bladder neoplasm surgery | Surgical and medical procedures | MedDRA (17.1) | Systematic Assessment |
| |
| Knee operation | Surgical and medical procedures | MedDRA (17.1) | Systematic Assessment |
| |
| Jugular vein thrombosis | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Catheter site erythema | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Device connection issue | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Extravasation | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Catheter site infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Vascular access complication | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
| |
| Blood fibrinogen decreased | Investigations | MedDRA (17.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Poor venous access | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA (17.1) | Systematic Assessment |
|
A 18-month post-study period is reserved for a joint, multi-center publication of study results. After this period, individual sites may publish results provided that the Sponsor is allowed 60 days to review any proposed publication for removal of confidential, protected, and trademarked material prior to submission with an option to delay publication up to 120 days if needed to protect its interests. The Sponsor shall retain the option to receive acknowledgment for its sponsorship of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AMBAR clinical manager | Grifols | +34 935712200 | AMBARclinical@grifols.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 31, 2018 | May 8, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| 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 |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C067831 | zidovudine 5'-monophosphate-mannose-albumin conjugate |
| C525853 | galactosamine-conjugated serum albumin-conjugated-(rhodamine X)20 |
| D007136 | Immunoglobulins |
| D005719 | gamma-Globulins |
| ID | Term |
|---|---|
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
|
|
|
|
|
| OG003 | Control (Sham) Group | Simulated plasma exchange procedure |
| OG004 | All Treated | All patients Treatment groups 1, 2 and 3 combined |
|
|
| Low Albumin |
Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period) |
| OG003 | Control (Sham) Group | Simulated plasma exchange procedure |
| OG004 | All Treated | All patients Treatment groups 1, 2 and 3 combined |
|
|
Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)
| OG003 | Control (Sham) Group | Simulated plasma exchange procedure |
| OG004 | All Treated | All patients Treatment groups 1, 2 and 3 combined |
|
|
| Low Albumin |
Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period) |
| OG003 | Control (Sham) Group | Simulated plasma exchange procedure |
| OG004 | All Treated | All patients Treatment groups 1, 2 and 3 combined |
|
|
Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period)
| OG003 | Control (Sham) Group | Simulated plasma exchange procedure |
| OG004 | All Treated | All patients Treatment groups 1, 2 and 3 combined |
|
|