Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-25 @ 5:25 PM
Study NCT ID:
NCT06677203
Status:
TERMINATED
Last Update Posted:
2025-06-29
First Post:
2024-11-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of ASN51 in Adults With Early Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials.gov@asceneuron.com', 'phone': '+41213538245', 'title': 'Asceneuron Clinical Research', 'organization': 'Asceneuron S.A.'}, 'certainAgreement': {'otherDetails': 'Agreement finally allows PI to publish independently.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.'}}, 'adverseEventsModule': {'timeFrame': 'AEs were not collected in this study.', 'description': 'The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.', 'eventGroups': [{'id': 'EG000', 'title': 'ASN51 10 mg', 'description': 'Participants received 10 mg of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ASN51 20 mg', 'description': 'Participants received 20 mg of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants received ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-Controlled intervention period.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASN51 Low Dose', 'description': 'Participants were to receive low dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG001', 'title': 'ASN51 High Dose', 'description': 'Participants were to receive high dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period.'}], 'timeFrame': 'From first dose up to end of the study up to Week 28', 'description': 'An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASN51 Low Dose', 'description': 'Participants were to receive low dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG001', 'title': 'ASN51 High Dose', 'description': 'Participants were to receive high dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period'}], 'timeFrame': 'Baseline up to Week 28', 'description': 'C-SSRS is used to assess the suicidality of participants and assessment includes "yes" or "no" responses for 5 questions, each related to suicidal ideation and suicidal behavior. Numeric ratings are provided for suicidal ideation (score ranges from 1 to 5, where higher scores indicate more suicidal ideation) and suicidal behavior (score ranges from 0 to 4 where higher total scores indicate more suicidal behavior).', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cerebrospinal Fluid (CSF) Plasma Tau Phosphorylated at Threonine-217 (pTau217) Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASN51 Low Dose', 'description': 'Participants were to receive low dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG001', 'title': 'ASN51 High Dose', 'description': 'Participants were to receive high dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period.'}], 'timeFrame': 'Baseline through Week 24', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CSF Total Tau Protein Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASN51 Low Dose', 'description': 'Participants were to receive low dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG001', 'title': 'ASN51 High Dose', 'description': 'Participants were to receive high dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period.'}], 'timeFrame': 'Baseline through Week 24', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Plasma pTau217 Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASN51 Low Dose', 'description': 'Participants were to receive low dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG001', 'title': 'ASN51 High Dose', 'description': 'Participants were to receive high dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period.'}], 'timeFrame': 'Baseline through Week 24', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MK-6240 Tau Positron Emission Tomography (PET) Signal Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASN51 Low Dose', 'description': 'Participants were to receive low dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG001', 'title': 'ASN51 High Dose', 'description': 'Participants were to receive high dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period.'}], 'timeFrame': 'Baseline through Week 24', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.'}, {'type': 'SECONDARY', 'title': 'Trough Plasma Concentration (Cmin) of ASN51 in Plasma at Steady State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASN51 Low Dose', 'description': 'Participants were to receive low dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG001', 'title': 'ASN51 High Dose', 'description': 'Participants were to receive high dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period.'}], 'timeFrame': 'Pre-dose on Day 1 and at multiple time points post-dose up to Week 24', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of ASN51 at Steady State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ASN51 Low Dose', 'description': 'Participants were to receive low dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG001', 'title': 'ASN51 High Dose', 'description': 'Participants were to receive high dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period.'}], 'timeFrame': 'Pre-dose on Day 1 and at multiple time points post-dose up to Week 24', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ASN51 Low Dose', 'description': 'Participants were to receive low dose of ASN51 orally, once daily (QD) for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'FG001', 'title': 'ASN51 High Dose', 'description': 'Participants were to receive high dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "A total of 123 participants with Alzheimer's disease (AD) were enrolled in the study. The study was terminated due to a strategic decision by the sponsor before randomization and hence no participants received treatment, and no data were collected or evaluated for this study."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'ASN51 Low Dose', 'description': 'Participants receive low dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'BG001', 'title': 'ASN51 High Dose', 'description': 'Participants were to receive high dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino'}, {'title': 'Not Hispanic or Latino'}, {'title': 'Unknown or Not Reported'}]}]}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native'}, {'title': 'Asian'}, {'title': 'Native Hawaiian or Other Pacific Islander'}, {'title': 'Black or African American'}, {'title': 'White'}, {'title': 'More than one race'}, {'title': 'Unknown or Not Reported'}]}]}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants'}], 'populationDescription': 'The study was terminated due to a strategic decision by the sponsor. No participants received treatment, and no data were collected or evaluated for this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-10-07', 'size': 14024438, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-06-13T05:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'whyStopped': 'Strategic decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2024-11-05', 'resultsFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2024-11-05', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-13', 'studyFirstPostDateStruct': {'date': '2024-11-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'From first dose up to end of the study up to Week 28', 'description': 'An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.'}, {'measure': 'Change From Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline up to Week 28', 'description': 'C-SSRS is used to assess the suicidality of participants and assessment includes "yes" or "no" responses for 5 questions, each related to suicidal ideation and suicidal behavior. Numeric ratings are provided for suicidal ideation (score ranges from 1 to 5, where higher scores indicate more suicidal ideation) and suicidal behavior (score ranges from 0 to 4 where higher total scores indicate more suicidal behavior).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Cerebrospinal Fluid (CSF) Plasma Tau Phosphorylated at Threonine-217 (pTau217) Through Week 24', 'timeFrame': 'Baseline through Week 24'}, {'measure': 'Change From Baseline in CSF Total Tau Protein Through Week 24', 'timeFrame': 'Baseline through Week 24'}, {'measure': 'Change From Baseline in Plasma pTau217 Through Week 24', 'timeFrame': 'Baseline through Week 24'}, {'measure': 'Change From Baseline in MK-6240 Tau Positron Emission Tomography (PET) Signal Through Week 24', 'timeFrame': 'Baseline through Week 24'}, {'measure': 'Trough Plasma Concentration (Cmin) of ASN51 in Plasma at Steady State', 'timeFrame': 'Pre-dose on Day 1 and at multiple time points post-dose up to Week 24'}, {'measure': 'Maximum Plasma Concentration (Cmax) of ASN51 at Steady State', 'timeFrame': 'Pre-dose on Day 1 and at multiple time points post-dose up to Week 24'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Alzheimer's Disease", 'ASN51'], 'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "The main purpose of this study is to evaluate the safety, tolerability, and effect on biomarkers of disease pathophysiology and pathology, pharmacokinetics (PK), and preliminary effects on measures of clinical efficacy of multiple doses of ASN51 in adult participants with early Alzheimer's disease (AD)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Male or female age 50 to 80 years.\n2. A clinical diagnosis of Alzheimer's disease (AD) at either the mild cognitive impairment or mild AD dementia stage per National Institute on Aging and the Alzheimer's Association, consistent with Stage 3 and Stage 4 in the Food and Drug Administration (FDA) draft guidance for early AD.\n3. Mini-Mental State Examination score of 20 to 28 (inclusive).\n4. A plasma pTau217 result consistent with the presence of amyloid pathology.\n5. Must have a care partner who, in the investigator's judgment, has frequent and sufficient contact with the participant as to be able to provide accurate information about the participant's cognitive and functional abilities. The care partner must be literate and provide informed consent.\n\nKey Exclusion Criteria:\n\n1. Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment (e.g., current history of substance abuse, uncontrolled vitamin B12 deficiency or abnormal thyroid function, stroke or other cerebrovascular condition, normal pressure hydrocephalus, Parkinson's Disease, Lewy body dementia, cerebral amyloid angiopathy, frontotemporal dementia) or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns.\n2. Non-amnestic presentation of AD as judged by the investigator.\n3. Woman of childbearing potential.\n4. Any prior or ongoing exposure to active or passive anti-amyloid immunotherapy, anti-tau immunotherapy, an anti-tau antisense oligonucleotide or gene therapy, or O-linked-β-N-acetylglucosaminidase (O-GlcNAcase) inhibitor.\n\nOther protocol defined inclusion and exclusion criteria could apply."}, 'identificationModule': {'nctId': 'NCT06677203', 'briefTitle': "Study of ASN51 in Adults With Early Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Asceneuron S.A.'}, 'officialTitle': "A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of ASN51 in Adults With Early Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'ASN51-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASN51: Low Dose', 'description': 'Participants were to receive low dose of ASN51 orally, once daily (QD) for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.', 'interventionNames': ['Drug: ASN51']}, {'type': 'EXPERIMENTAL', 'label': 'ASN51: High Dose', 'description': 'Participants were to receive high dose of ASN51 orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period or up to 36 weeks long-term extension period.', 'interventionNames': ['Drug: ASN51']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants were to receive ASN51 matching placebo orally, QD for up to 24 weeks in the double-blind placebo-controlled intervention period.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ASN51', 'type': 'DRUG', 'description': 'Oral capsules', 'armGroupLabels': ['ASN51: High Dose', 'ASN51: Low Dose']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34711', 'city': 'Clermont', 'state': 'Florida', 'country': 'United States', 'facility': 'K2 Medical Research', 'geoPoint': {'lat': 28.54944, 'lon': -81.77285}}, {'zip': '32159', 'city': 'Lady Lake', 'state': 'Florida', 'country': 'United States', 'facility': 'K2 Medical Research - The Villages', 'geoPoint': {'lat': 28.91749, 'lon': -81.92286}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'K2 Medical Research', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '34997', 'city': 'Stuart', 'state': 'Florida', 'country': 'United States', 'facility': "Alzheimer's Treatment and Research Center", 'geoPoint': {'lat': 27.19755, 'lon': -80.25283}}, {'zip': '33414', 'city': 'Wellington', 'state': 'Florida', 'country': 'United States', 'facility': "Alzheimer's Treatment and Research Center", 'geoPoint': {'lat': 26.65868, 'lon': -80.24144}}, {'zip': '31909', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Columbus Memory Center, LLC', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Re:Cognition Health', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asceneuron S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}