Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2013-005576-18 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study determined the safety of CNP520 in healthy elderly over 3 months. Data relevant for Pharmacokinetic/Pharmacodynamic modeling were obtained in order to define the target dose in subsequent efficacy studies.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks. |
|
| CNP520 2 mg | Experimental | CNP520 2 mg was taken qd orally for 13 weeks. |
|
| CNP520 10 mg | Experimental | CNP520 10 mg was taken qd orally for 13 weeks. |
|
| CNP520 35 mg | Experimental | CNP520 35 mg was taken qd orally for 13 weeks. |
|
| CNP520 85 mg | Experimental | CNP520 85 mg was taken qd orally for 13 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNP520 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths | Safety monitoring was conducted throughout the study. | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations | CSF samples were collected by lumbar puncture for assessment. | Day 92 |
| Summary of Plasma PK Parameter: Cmax |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Glendale | California | 91206 | United States | ||
| Novartis Investigative Site |
Participants were randomized in a 1:1:1:1:1 ratio to 5 treatment groups: placebo, CNP520 2 mg, CNP520 10 mg, CNP520 35 mg and CNP520 85 mg.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks. |
| FG001 | CNP520 2 mg | CNP520 2 mg was taken qd orally for 13 weeks. |
| FG002 | CNP520 10 mg | CNP520 10 mg was taken qd orally for 13 weeks. |
| FG003 | CNP520 35 mg | CNP520 35 mg was taken qd orally for 13 weeks. |
| FG004 | CNP520 85 mg | CNP520 85 mg was taken qd orally for 13 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks. |
| BG001 | CNP520 2 mg | CNP520 2 mg was taken qd orally for 13 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Subjects With Non-serious and Serious Adverse Events (AEs) and Deaths | Safety monitoring was conducted throughout the study. | The safety analysis set, which included participants who received at least 1 dose of study drug (CNP520 or placebo), was analyzed. | Posted | Number | Participants | 13 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D058225 | Plaque, Amyloid |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628578 | Umibecestat |
| D002214 | Capsules |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Matching placebo to CNP520 was supplied in capsules. |
|
Cmax = the observed maximum plasma concentration following drug administration. Blood samples were collected to assess Cmax. The PK analysis set was used for the analysis.
| Days 1, 91 |
| Summary of Plasma PK Parameter: AUCtau | AUCtau = the area under the plasma concentration-time curve from zero to the end of the dosing interval tau. Blood samples were collected to assess AUCtau. | Days 1 and 91 |
| Summary of Plasma PK Parameter: Tmax | Tmax = the time to reach the maximum concentration after drug administration. Blood samples were collected to assess Tmax. | Days 1 and 91 |
| Summary of Plasma PK Parameter: Tlag | Tlag = time delay between drug administration and first observed concentration above the lower limit of quantification (LOQ) in plasma . Blood samples were collected to assess Tlag. | Days 1 and 91 |
| Summary of Plasma PK Parameter: T1/2 | T1/2 = the terminal elimination half-life. Blood samples were collected to assess T/12. | Day 91 |
| Summary of PK Parameter: CLss/F | CLss/F = the apparent systemic clearance from plasma observed during a dosing interval at steady state following extravascular administration. Blood samples were collected to assess CLss/F. | Day 91 |
| Summary of Plasma PK Parameter: Racc | Racc = the accumulation ratio . Blood samples were collected to assess Racc. | Day 91 |
| Summary of CSF PK Concentrations | CSF samples were collected by lumbar puncture for assessment. | Days 1, 14, 28, 42, 56, 70 and 91 |
| Area-under-plasma Concentration Time Curve up to Infinity (AUCinf) | CNP520 concentrations in plasma | Day 91 |
| Apparent Volume of Distribution (Vz/F) | Day 91 |
| Long Beach |
| California |
| 90806 |
| United States |
| Novartis Investigative Site | Miami | Florida | 33126 | United States |
| Novartis Investigative Site | Lincoln | Nebraska | 68502 | United States |
| Novartis Investigative Site | Antwerp | 2060 | Belgium |
| Novartis Investigative Site | Berlin | 14050 | Germany |
| Novartis Investigative Site | Groningen | GZ | 9713 | Netherlands |
| Novartis Investigative Site | Leiden | 2333 CL | Netherlands |
| Novartis Investigative Site | Belfast | Northern Ireland | BT9 6AD | United Kingdom |
| Novartis Investigative Site | Harrow | HA1 3UJ | United Kingdom |
| Novartis Investigative Site | Mid Glamorgan | CF484DR | United Kingdom |
| Adverse Event |
|
| Physician Decision |
|
| BG002 | CNP520 10 mg | CNP520 10 mg was taken qd orally for 13 weeks. |
| BG003 | CNP520 35 mg | CNP520 35 mg was taken qd orally for 13 weeks. |
| BG004 | CNP520 85 mg | CNP520 85 mg was taken qd orally for 13 weeks. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
CNP520 10 mg was taken qd orally for 13 weeks. |
| OG003 | CNP520 35 mg | CNP520 35 mg was taken qd orally for 13 weeks. |
| OG004 | CNP520 85 mg | CNP520 85 mg was taken qd orally for 13 weeks. |
|
|
| Secondary | Change From Baseline of Amyloid Beta (Aβ) 1-38 , Aβ 1-40 and Aβ 1-42 Cerebrospinal Fluid (CSF) Concentrations | CSF samples were collected by lumbar puncture for assessment. | The pharmacodynamics (PD) analysis set was analyzed. The PD set included only randomized participants who had available PD data and no protocol deviations with relevant impact on PD data. | Posted | Mean | Standard Deviation | Percentage change | Day 92 |
|
|
|
| Secondary | Summary of Plasma PK Parameter: Cmax | Cmax = the observed maximum plasma concentration following drug administration. Blood samples were collected to assess Cmax. The PK analysis set was used for the analysis. | The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point. | Posted | Mean | Standard Deviation | ng/mL | Days 1, 91 |
|
|
|
| Secondary | Summary of Plasma PK Parameter: AUCtau | AUCtau = the area under the plasma concentration-time curve from zero to the end of the dosing interval tau. Blood samples were collected to assess AUCtau. | The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point. | Posted | Mean | Standard Deviation | h*ng/mL | Days 1 and 91 |
|
|
|
| Secondary | Summary of Plasma PK Parameter: Tmax | Tmax = the time to reach the maximum concentration after drug administration. Blood samples were collected to assess Tmax. | The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point. | Posted | Median | Full Range | hour | Days 1 and 91 |
|
|
|
| Secondary | Summary of Plasma PK Parameter: Tlag | Tlag = time delay between drug administration and first observed concentration above the lower limit of quantification (LOQ) in plasma . Blood samples were collected to assess Tlag. | The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point. | Posted | Median | Full Range | hour | Days 1 and 91 |
|
|
|
| Secondary | Summary of Plasma PK Parameter: T1/2 | T1/2 = the terminal elimination half-life. Blood samples were collected to assess T/12. | The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed. | Posted | Mean | Standard Deviation | hour | Day 91 |
|
|
|
| Secondary | Summary of PK Parameter: CLss/F | CLss/F = the apparent systemic clearance from plasma observed during a dosing interval at steady state following extravascular administration. Blood samples were collected to assess CLss/F. | The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed. | Posted | Mean | Standard Deviation | mL/h | Day 91 |
|
|
|
| Secondary | Summary of Plasma PK Parameter: Racc | Racc = the accumulation ratio . Blood samples were collected to assess Racc. | The PK analysis set was used for the analysis. Only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed. | Posted | Mean | Standard Deviation | ratio | Day 91 |
|
|
|
| Secondary | Summary of CSF PK Concentrations | CSF samples were collected by lumbar puncture for assessment. | The PK analysis set was used for the analysis. For a given time point, only those participants from the PK analysis set, who had PK data and had no protocol deviations with relevant impact on PK data, were analyzed for that time point. | Posted | Mean | Standard Deviation | ng/mL | Days 1, 14, 28, 42, 56, 70 and 91 |
|
|
|
| Secondary | Area-under-plasma Concentration Time Curve up to Infinity (AUCinf) | CNP520 concentrations in plasma | This PK parameter was not analyzed because data was not collected. | Posted | Day 91 |
|
|
| Secondary | Apparent Volume of Distribution (Vz/F) | This PK parameter was not analyzed because data was not collected. | Posted | Day 91 |
|
|
| 0 |
| 24 |
| 18 |
| 24 |
| EG001 | CNP520 2mg | CNP520 2 mg was taken qd orally for 13 weeks. | 0 | 25 | 19 | 25 |
| EG002 | CNP520 10mg | CNP520 10 mg was taken qd orally for 13 weeks. | 0 | 25 | 22 | 25 |
| EG003 | CNP520 35mg | CNP520 35 mg was taken qd orally for 13 weeks. | 1 | 26 | 20 | 26 |
| EG004 | CNP520 85mg | CNP520 85 mg was taken qd orally for 13 weeks. | 0 | 24 | 18 | 24 |
| Ear discomfort | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Eustachian tube dysfunction | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Asthenopia | Eye disorders | MedDRA | Systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Eructation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Faeces hard | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Glossodynia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA | Systematic Assessment |
|
| Feeling cold | General disorders | MedDRA | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment |
|
| Puncture site pain | General disorders | MedDRA | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA | Systematic Assessment |
|
| Vessel puncture site pain | General disorders | MedDRA | Systematic Assessment |
|
| Vessel puncture site swelling | General disorders | MedDRA | Systematic Assessment |
|
| Allergy to chemicals | Immune system disorders | MedDRA | Systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Abscess jaw | Infections and infestations | MedDRA | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Ear abrasion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Foreign body in eye | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post procedural discomfort | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Procedural complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Traumatic lumbar puncture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Amylase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA | Systematic Assessment |
|
| Lipase increased | Investigations | MedDRA | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Visual field defect | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Abnormal dreams | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Affective disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Obsessive thoughts | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Pruritus genital | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aβ 1-40 |
|
| Aβ 1-42 |
|
| Day 91 (=23,22,24,20) |
|
| Day 91 (n=23,22,24,20) |
|
| Day 91 (n=23,22,24,20) |
|
| Day 91 (n=23,22,24,20) |
|
| Day 14 (n=3,4,4,4) |
|
| Day 28 (n=5,2,7,5) |
|
| Day 42 (n=3,6,5,5) |
|
| Day 56 (n=5,5,2,4) |
|
| Day 70 (n=6,5,6,4) |
|
| Day 91 (n=23,21,24,20) |
|