Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-27 @ 11:03 PM
Study NCT ID:
NCT06339034
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-08
First Post:
2024-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repurposing Lithium for Parkinson's Disease: a RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008094', 'term': 'Lithium'}], 'ancestors': [{'id': 'D008672', 'term': 'Metals, Alkali'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-blind, placebo-controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2024-03-24', 'studyFirstSubmitQcDate': '2024-03-24', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'Throughout 24 week study', 'description': 'Number of patients with any and serious adverse events and number who withdraw from the study.'}], 'primaryOutcomes': [{'measure': 'MRI-derived free water (FW) levels.', 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'FW in the posterior substantia nigra (pSN), dorsomedial nucleus of the thalamus (DMN-T) and the nucleus basalts of Meynert (nbM).'}, {'measure': 'Peripheral blood mononuclear cell (PBMC) nuclear receptor-related 1 protein (Nurr1) mRNA expression', 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'PBMC Nurr1 mRNA expression using Taqman PCR.'}, {'measure': 'Serum neurofilament light chain (NfL)', 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'Serum NfL assessed using SIMOA platform by Quanterix (Lexington, MA)'}], 'secondaryOutcomes': [{'measure': 'PBMC superoxide dismutase type-1 (SOD-1) mRNA expression', 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'PBMC SOD-1 mRNA expression using Taqman PCR'}, {'measure': 'PBMC pS9/total glycogen synthase kinase-3B (GSK-3B) ratio', 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'Assessed using ELISA'}, {'measure': 'PBMC pThr308 and pS473/total protein kinase B (Akt) ratios', 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'Assessed using ELISA'}, {'measure': 'Serum interleukin-6', 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'Assessed using ELISA'}, {'measure': 'Serum glial fibrillary acidic protein (GFAP)', 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'Serum GFAP assessed using SIMOA platform by Quanterix (Lexington, MA)'}, {'measure': "Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (Motor Examination)", 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'Assessed in the "on" state. Score range 0-132 with higher scores indicating worse outcomes.'}, {'measure': 'Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'Score range 0-30 with higher scores indicating better outcomes.'}, {'measure': "Parkinson's Anxiety Scale", 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'Score range 0-48 with higher scores indicating worse outcomes.'}, {'measure': 'Geriatric Depression Scale-15', 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'Score range 0-15 with higher scores indicating worse outcomes.'}, {'measure': 'Fatigue Severity Scale', 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'Score range 9-63 with higher scores indicating worse outcomes.'}, {'measure': 'Insomnia Severity Index', 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'Score range 0-28 with higher scores indicating worse outcomes.'}, {'measure': "Parkinson's Disease Questionnaire-8", 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'Score range 0-32 with higher scores indicating worse outcomes.'}, {'measure': 'Levodopa equivalent daily dose (LEDD)', 'timeFrame': 'Change from baseline (BL) to 24 week', 'description': 'Higher scores indicate higher dose of dopaminergic therapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's", 'Lithium', 'Free water', 'Disease-modifying therapy'], 'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '37215748', 'type': 'BACKGROUND', 'citation': "Guttuso T Jr, Shepherd R, Frick L, Feltri ML, Frerichs V, Ramanathan M, Zivadinov R, Bergsland N. Lithium's effects on therapeutic targets and MRI biomarkers in Parkinson's disease: A pilot clinical trial. IBRO Neurosci Rep. 2023 May 7;14:429-434. doi: 10.1016/j.ibneur.2023.05.001. eCollection 2023 Jun."}]}, 'descriptionModule': {'briefSummary': "This study will examine the effects of lithium 20mg/day compared to placebo on MRI and blood-based biomarkers among 20 early-stage Parkinson's disease patients.", 'detailedDescription': "In observational studies, small daily doses of lithium have been associated with a 77% reduced risk of developing Parkinson's disease (PD). In addition, lithium therapy has been effective in preventing neuronal death and behavioral symptoms in several PD animal models. Recently, our group has shown 24-weeks of low-dose lithium therapy in PD to improve both MRI and blood-based biomarkers implying that lithium may be slowing the progression of the disease. However, these findings stem from only three of four patients receiving MRIs. A larger study will be required to determine if these promising results can be replicated. The proposed study will enroll 20 additional PD patients who will be randomly assigned to receive either lithium 20mg/day or identically-appearing placebo capsules for 24 weeks. This will be a double-blind study meaning that neither the patients nor the study team will know to which therapy patients have been assigned. Positive results from this study will support further research on lithium that could eventually support lithium as a disease-modifying therapy for PD that could improve patients' long-term prognoses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have PD for \\<4 years diagnosed by a movement disorder specialist. Have normal thyroid and renal function at the screening visit. Have no previous exposure to lithium therapy. Have no history of brain surgery. Have no hx of brain imaging findings suggesting another neurological condition besides PD.\n\nHave no use of tobacco or THC products for \\>1 year. Have stable PD medications for \\>30 days without current need for adjustments in the investigator's opinion.\n\nHave stable psychiatric and diuretic medications for \\>60 days with no anticipated need for changes for at least 24 weeks.\n\nHave no active medical or psychiatric condition that may interfere with study procedures in the investigator's opinion.\n\nExclusion Criteria:\n\n* Have PD for \\>4 years or does not have PD. Have abnormal normal thyroid and renal function at the screening visit. Have previous exposure to lithium therapy. Have history of brain surgery. Have hx of brain imaging findings suggesting another neurological condition besides PD.\n\nHave use of tobacco or THC products within the past year. Have PD medication adjustments within 30 days or needs PD medication adjustments in the investigator's opinion.\n\nHave psychiatric or diuretic medication adjustments within the last 60 days or is anticipated to need changes over next 24 weeks.\n\nHave active medical or psychiatric condition that may interfere with study procedures in the investigator's opinion."}, 'identificationModule': {'nctId': 'NCT06339034', 'briefTitle': "Repurposing Lithium for Parkinson's Disease: a RCT", 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': "Repurposing Lithium as a Disease-modifying Therapy in Parkinson's Disease: A Randomized Controlled Trial", 'orgStudyIdInfo': {'id': 'STUDY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lithium', 'description': 'Lithium: 10mg, 2x/day', 'interventionNames': ['Dietary Supplement: Lithium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Identical capsules filled with cellulose: 10mg, 2x/day', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Lithium', 'type': 'DIETARY_SUPPLEMENT', 'description': '5mg of elemental lithium/capsule', 'armGroupLabels': ['Lithium']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Cellulose-filled capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14221', 'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': 'UBMD Neurology', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be considered on a case-by-case basis.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'collaborators': [{'name': "Cure Parkinson's", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology', 'investigatorFullName': 'Thomas Guttuso', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}