Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-25 @ 8:06 PM
Study NCT ID:
NCT04075435
Status:
RECRUITING
Last Update Posted:
2025-05-08
First Post:
2019-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D011595', 'term': 'Psychomotor Agitation'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'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'}, {'id': 'D020820', 'term': 'Dyskinesias'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This is an open label trial; all participants will receive active drug.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-01-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2019-08-29', 'studyFirstSubmitQcDate': '2019-08-29', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total clinical impression column score on neuropsychiatric inventory agitation and aggression domains (NPI-C)', 'timeFrame': 'Continuous, weeks 0-8', 'description': 'Exploratory measure to see reduction in agitation and aggression symptoms'}, {'measure': 'Total score of Cohen-Mansfield Inventory (CMAI)', 'timeFrame': 'Continuous, weeks 0-8', 'description': 'Exploratory measure to see reduction in agitation symptoms'}, {'measure': 'Total Score of Zarit Caregiver Burden Interview', 'timeFrame': 'Continuous, weeks 0-8', 'description': 'Exploratory downstream reduction in caregiver burden'}, {'measure': 'Stability of anxiety and agitation reduction using anxiety domain of NPI-C and GAD-7', 'timeFrame': 'Months 3, 6, 9, and 12 of the optional follow-up phase', 'description': 'Exploratory investigation into the stability of anxiety reduction using the anxiety domain score on the NPI-C and the GAD-7 during the optional follow-up phase'}, {'measure': 'Stability of caregiver burden reduction', 'timeFrame': 'Months 3, 6, 9, and 12 of the optional follow-up phase', 'description': 'Exploratory investigation into reduction of caregiver burden using the Zarit Caregiver Burden Interview during the optional follow-up phase'}], 'primaryOutcomes': [{'measure': 'Total of clinician impression column on anxiety domain of the NPI-C', 'timeFrame': 'Continuous, weeks 0-8', 'description': 'Measure of Anxiety Domain on the Neuropsychiatric Inventory-Clinician scale'}], 'secondaryOutcomes': [{'measure': 'Total score on the Generalized Anxiety Disorder 7 scale', 'timeFrame': 'Continuous, week 0-8', 'description': 'Secondary Outcome Measure of anxiety reduction'}, {'measure': 'Number of serious adverse events', 'timeFrame': 'Continuous, weeks 0-8', 'description': 'Secondary Outcome Measure of safety defined by absence of serious adverse events'}, {'measure': 'Week 8 MMSE total score compared to baseline MMSE total score', 'timeFrame': 'longitudinal: screening/baseline and week8', 'description': 'Secondary Outcome Measure of safety as defined by lack of treatment emergent cognitive impairment as measured by the Mini Mental Status Exam (MMSE)'}, {'measure': 'Score on the confusion assessment method', 'timeFrame': 'Continuous screening weeks 0-8, dichotomous', 'description': 'Secondary Outcome Measure of safety defined as absence of treatment emergent delirium as measured by the Confusion Assessment Method (CAM)'}, {'measure': 'Number and severity of side effects reported', 'timeFrame': 'Continuous, weeks 0-8', 'description': 'Secondary Outcome Measure of safety defined as a low number of emergent somatic side effects as measured by the Medication Side Effects Questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cannabidiol', 'older adults', 'dementia'], 'conditions': ['Alzheimer Disease', 'Anxiety', 'Agitation,Psychomotor', "Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of probable Alzheimer's Dementia via criteria from McKhann et al., or MCI\n2. MMSE score of 15-30 (inclusive)\n3. Clinically significant degree of anxiety, as defined by a Clinical Impression total column score of ≥4 on the Anxiety domain of the NPI-C\n4. A health care proxy available to sign consent on behalf of the participant (if applicable)\n5. A caregiver who spends at least 10 hours per week with the subject who is able to attend all study visits\n6. Participants and their study partner must be fluent in English\n7. Must be 55-90 years old (inclusive)\n\nExclusion Criteria:\n\n1. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes.\n2. Seizure disorder\n3. Lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, as determined by the MINI\n4. Current episode of major depression, as determined by the MINI\n5. Active substance abuse or dependence within the past 6 months, as determined by the MINI\n6. Delirium (as measured by the CAM)\n7. Current inpatient hospitalization\n8. Current regular use of cannabinoid products (\\>1 use per month)\n9. Positive urine screen for THC at the screening or baseline visit\n10. Allergy to coconut\n11. Participants taking strong inhibitors or inducers of CYP3A4 (e.g. fluconazole, fluoxetine, fluvoxamine, ticlopidine, St. John's Wort, etc.), CYP2C19 (ketoconazole, erythromycin, etc.), or anti-epileptic drugs"}, 'identificationModule': {'nctId': 'NCT04075435', 'acronym': 'CBD', 'briefTitle': "Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia", 'organization': {'class': 'OTHER', 'fullName': 'Mclean Hospital'}, 'officialTitle': "Open-Label Trial of a Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia", 'orgStudyIdInfo': {'id': '2019P002466'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'All subjects', 'description': 'This arm will include all subjects, individuals will administer a high CBD, low THC full spectrum sublingual solution twice daily on a variable dosing schedule.', 'interventionNames': ['Drug: high CBD/low THC sublingual solution']}], 'interventions': [{'name': 'high CBD/low THC sublingual solution', 'type': 'DRUG', 'description': 'Hemp derived solution to be administered sublingually twice daily.', 'armGroupLabels': ['All subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02478', 'city': 'Belmont', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ipsit V Vahia, MD', 'role': 'CONTACT', 'email': 'ivahia@mclean.harvard.edu', 'phone': '617-855-3291'}, {'name': 'Staci Gruber, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ipsit Vahia, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'McLean Hospital', 'geoPoint': {'lat': 42.39593, 'lon': -71.17867}}], 'centralContacts': [{'name': 'Emily H Kim, BS', 'role': 'CONTACT', 'email': 'ekim76@mgb.org', 'phone': '617-855-2562'}, {'name': 'Rosemary Smith, MS', 'role': 'CONTACT', 'email': 'rsmith@mclean.harvard.edu', 'phone': '617-855-2908'}], 'overallOfficials': [{'name': 'Staci Gruber, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mclean Hospital'}, {'name': 'Ipsit V Vahia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mclean Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mclean Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Spier Family Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Directory, Cognitive and Clinical Neuroimaging Core; Director, Marijuana Investigations for Neuroscientific Discovery (MIND)', 'investigatorFullName': 'Staci Gruber, Ph.D.', 'investigatorAffiliation': 'Mclean Hospital'}}}}