Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-17 @ 12:12 AM
Study NCT ID:
NCT06427668
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-17
First Post:
2024-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "Phase 2 randomized, double-blind, placebo-controlled safety and tolerability study in adult participants with Alzheimer's Disease"}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-13', 'studyFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2024-05-19', 'lastUpdatePostDateStruct': {'date': '2025-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Electroencephalogram (EEG) at resting state and at auditory evoked P300 from baseline to endpoint', 'timeFrame': '8 months', 'description': 'Electroencephalogram (EEG) will provide non-invasive measurement of brain activity. This test will be used to measure resting state cognitive activity as well as cognitive activity after auditory stimulation. Sound stimuli is 500Hz and 2000Hz.'}, {'measure': "Change in Alzheimer's Disease Assessment Scale-Cog (ADAS-COG) total score from baseline to endpoint", 'timeFrame': '8 months', 'description': "The Alzheimer's Disease Assessment Scale-Cognitive Subscale test (ADAS-Cog) measures language and memory, focusing on cognitive and non-cognitive functioning. It evaluates word recall, naming of objects, word recognition, comprehension and word finding. The ADAS-COG is scored 0-70. The higher the score the greater the impairment."}, {'measure': 'Change in Mini-Mental State Examination (MMSE) from baseline to endpoint', 'timeFrame': '8 months', 'description': 'The Mini-Mental State Exam (MMSE) is a test of cognitive function. It includes tests of orientation, attention, memory, language and visual-spatial skills. The lower the score the greater the impairment.'}, {'measure': 'C-SSRS (Columbia Suicide Severity Rating Scale)', 'timeFrame': '8 months', 'description': 'Prospective suicidality assessment is performed using the Columbia-Suicide Severity Rating Scale (C-SSRS), a questionnaire to evaluate suicidal ideation and behavior. Answer "yes" on item 4 or 5 of the Suicidal Ideation section or "yes" on any item of the Suicidal Behavior section is considered positive. The suicidal behavior lethality sub-scale inquires about the level of actual or potential medical damage.'}, {'measure': "Change in Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) from baseline to endpoint", 'timeFrame': '8 months', 'description': "The Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS - CGIC) is a metric for clinical assessment of symptom severity. It consists of 2 parts. First a baseline evaluation of patient and caregiver is performed to collect necessary clinical information. The clinician will then conduct the second phase of the assessment after a specified time period, and changes in symptom severity are indicated on a seven point scale. A higher scale indicates a worsening of symptoms."}, {'measure': "Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale from baseline to endpoint", 'timeFrame': '8 months', 'description': "The Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale is an scale that assesses the performance of daily tasks and activities. A lower score indicates lower functional performance."}, {'measure': "Quality of Life in Alzheimer's Disease (QOL-AD) from baseline to endpoint", 'timeFrame': '8 months', 'description': "The Quality of Life in Alzheimer's Disease (QOL-AD) is a test to evaluate the quality of life through a series of questions of ability to complete daily activities and tasks. A lower score indicates lower functional quality of life."}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of SPG302', 'timeFrame': '8 months', 'description': 'Incidence, nature and severity of adverse events (AEs) and serious adverse events (SAEs)'}, {'measure': 'Plasma pharmacokinetics of SPG302 in participants with AD-Maximum Plasma Concentration (Cmax)', 'timeFrame': '8 months', 'description': 'Blood will be collected following administration of SPG302 and plasma levels will be evaluated to measure the maximum concentration.'}, {'measure': 'Change in biomarkers in participants with AD from baseline to endpoint.', 'timeFrame': '8 months', 'description': 'To assess the effect of SPG302 on Neurofilament light (NfL), a protein elevated in AD. This will be measured in picometers/milliliter.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alzheimer Disease', 'synapse', 'neural connectivity', 'Dementia'], 'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'This phase 2 study will evaluate the safety, tolerability, clinical efficacy, pharmacokinetics, and pharmacodynamics of SPG302 in adult participants with mild-to-moderate AD.', 'detailedDescription': 'This is a phase 2, multicenter study to assess the safety, tolerability, CNS effects, pharmacokinetics, pharmacodynamics and clinical efficacy of SPG302 in adult participants with mild-to-moderate AD. The study will consist of 2 parts:\n\nPart A: Placebo-controlled, randomized, safety and preliminary efficacy cohort with daily dosing for 28 day cycles\n\nPart B: a randomized expansion cohort of daily dosing for 28 day cycles'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 45-85\n* Diagnosis of mild to moderate AD\n* Clinical laboratory values within normal range or \\< 1.5 times ULN\n* If receiving AD-specific treatment, have been on stable dose for ≥ 3 months prior to first dose of study drug.\n* Life expectancy of \\>2 years\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Any physical or psychological condition that prohibits study completion\n* Known cardiac disease\n* Active or history of malignancy in the past 5 years\n* Serious infection that will not be resolved by first day of study intervention.\n* History of clinically significant CNS event or diagnosis in the past 5 years.\n* Acute illness within 30 days of Day 1\n* History of suicidal behavior or suicidal ideation\n* History of chronic alcohol use or substance abuse in the last 5 years\n* HIV, hepatitis B and/or hepatitis C positive\n* Vaccines within 14 days\n* Receipt of investigational products within 30 days\n* Blood donation within 30 days\n* Pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT06427668', 'briefTitle': "Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimer's Disease (AD)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Spinogenix'}, 'officialTitle': "A Phase 2, Randomized, Placebo-controlled, Double-Blind Multicenter Study to Assess the Safety, Tolerability, and Pharmacodynamics (PD) in Adult Participants With Mild-to Moderate Alzheimer's Disease (AD) Administered SPG302", 'orgStudyIdInfo': {'id': 'SPG302-ALZ-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Part A: Active SPG302 to be administered to adult participants with AD', 'description': "Cohort 1: 12 participants with Alzheimer's Disease will be randomized in a 2:1 ratio to receive SPG302 or placebo. Study intervention will be 300 mg orally once daily for 28 days (cycle 1). All participants will receive open-label SPG302 for cycles 2-7. This arm may be expanded to cohort 2: 12 additional participants pending review of data, for additional dose exploration.", 'interventionNames': ['Drug: SPG302']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Placebo comparator to be administered to adult participants with AD', 'description': "Cohort 1: 12 participants with Alzheimer's Disease will be randomized in a 2:1 ratio to receive SPG302 or placebo. Study intervention will be placebo capsule orally daily for 28 days (cycle 1). All participants will receive open-label SPG302 for cycles 2-7. This arm may be expanded to 12 additional participants as cohort 2 pending review of data, for additional dose exploration.", 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Expansion Cohort', 'description': 'Dose to be used and size of dosing cohort to be determined by Data Safety and Monitoring Committee following completion of Part A.', 'interventionNames': ['Drug: SPG302']}], 'interventions': [{'name': 'SPG302', 'type': 'DRUG', 'description': 'synthetic small molecule', 'armGroupLabels': ['Part A: Active SPG302 to be administered to adult participants with AD', 'Part B: Expansion Cohort']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Part A: Placebo comparator to be administered to adult participants with AD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Flinders Medical center', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Lauren Priest, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Flinders Medical Center, Adelaide, SA, Australia'}, {'name': 'Brew Brew, MBBS,MD,DSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Vincents Hospital, Sydney, NSW, Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spinogenix', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}