Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 4:41 AM
Study NCT ID:
NCT07328451
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2025-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Sponsor staff directly interacting with the site (clinical operations and medical monitor) will be blinded but may be unblinded if necessary to ensure participant safety.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-20', 'studyFirstSubmitDate': '2025-12-24', 'studyFirstSubmitQcDate': '2025-12-24', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of treatment-emergent adverse events (TEAEs) throughout the double-blind period', 'timeFrame': '37 weeks'}], 'secondaryOutcomes': [{'measure': 'PK parameter: Maximum concentration (Cmax) of DNL628 in plasma', 'timeFrame': '37 weeks'}, {'measure': 'PK Parameter: Time to reach maximum concentration (tmax) of DNL628 in plasma', 'timeFrame': '37 weeks'}, {'measure': 'PK Parameter: Minimum concentration (Cmin) of DNL628 in plasma', 'timeFrame': '37 weeks'}, {'measure': 'PK Parameter: Area under the concentration-time curve (AUC) from time zero to time of last measurable concentration (AUClast) of DNL628 in plasma', 'timeFrame': '37 weeks'}, {'measure': 'PK Parameter: AUC from time 0 to the end of the dosing interval (AUCτ) of DNL628 in plasma', 'timeFrame': '37 weeks'}, {'measure': 'PK Parameter: terminal elimination half-life (t1/2) of DNL628 in plasma', 'timeFrame': '37 weeks'}, {'measure': 'PK Parameter: Accumulation ratio of DNL628 in plasma', 'timeFrame': '37 weeks'}, {'measure': 'Change from baseline in total tau and ptau181 as measured in CSF', 'timeFrame': '25 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Alzheimer's Disease"], 'conditions': ['Alzheimer Disease, Early Onset']}, 'descriptionModule': {'briefSummary': "This is a Phase 1b, multicenter, randomized, placebo-controlled, double-blind, multiple ascending dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of DNL628 in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment, or mild AD with biomarker evidence of amyloid positivity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* BMI of ≥18 to \\< 32 kg/m2 and body weight of ≥45 kg\n* Have a diagnosis of probable AD dementia based on NIA AA 2011 criteria, including amnestic or nonamnestic presentation at screening\n* Have supportive evidence of AD pathology via historical records or laboratory testing at screening for amyloid positivity\n* Have AD severity defined as the following at screening:\n\n * A Clinical Dementia Rating global score of 0.5 or 1\n * A Mini-Mental State Examination score of 20 to 30 (inclusive)\n\nKey Exclusion Criteria:\n\n* Have clinically significant neurological or cognitive disorders affecting the CNS other than AD, as determined by the investigator\n* Have clinically significant psychiatric conditions\n* Have any history of unstable or poorly controlled endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, hematological, or other significant medical condition that, in the opinion of the investigator, may interfere with the completion or interpretation of study assessment\n* Have had a malignancy within 5 years before screening, except fully resected basal cell carcinoma or other malignancies (such as prostate cancer) at low risk of recurrence, depending on investigator and medical monitor agreement\n* Have had previous anti amyloid or anti tau immunotherapy (including active immunization)\n\n * Note: ADAD participants who have participated in previous passive anti-amyloid immunotherapy \\> 6 months previously will be allowed, contingent on investigator and Sponsor agreement\n* Have had previous exposure to gene therapy'}, 'identificationModule': {'nctId': 'NCT07328451', 'briefTitle': "A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Denali Therapeutics Inc.'}, 'officialTitle': "A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL628 in Participants With Early Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'DNLI-K-0001'}, 'secondaryIdInfos': [{'id': '2025-523515-11-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Arm', 'interventionNames': ['Drug: DNL628']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Arm', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'DNL628', 'type': 'DRUG', 'description': 'Multiple ascending doses', 'armGroupLabels': ['Experimental Arm']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Multiple ascending doses', 'armGroupLabels': ['Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1N 3BG', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'facility': 'Clinical Site(s)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Clinical Trials at Denali Therapeutics', 'role': 'CONTACT', 'email': 'clinical-trials@dnli.com', 'phone': 'Email:'}], 'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Denali Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Denali Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}