Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT05383833
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2022-04-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Creatine to Augment Bioenergetics in Alzheimer's
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003401', 'term': 'Creatine'}], 'ancestors': [{'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2022-04-20', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence to Creatine Monohydrate Intervention', 'timeFrame': '8 weeks', 'description': 'Participants will keep a daily supplement tracker (with the help of a consenting study partner). They will also bring unconsumed creatine monohydrate powder to study visits where study personnel will measure and validate against expected intake.'}, {'measure': 'Change in Blood Creatine', 'timeFrame': 'Baseline, 4 weeks, and 8 weeks', 'description': 'Measure of serum creatine levels at baseline, 4 weeks, and 8 weeks.'}], 'secondaryOutcomes': [{'measure': 'Change in Brain Creatine Status', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Brain total creatine levels are measured in the brain using magnetic resonance spectroscopy in a 3 T clinical scanner.'}, {'measure': 'Change in Cognition', 'timeFrame': 'Baseline and 8 weeks', 'description': 'NIH Toolbox (NIH-TB) Cognition Battery will be used to assess changes in a composite global cognition score at baseline and 8 weeks.'}, {'measure': 'Change in Peripheral Mitochondrial Respiration', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Blood platelet and leukocyte mitochondrial respiration (oxygen consumption) will be determined using the Oroboros Oxygraph-2K system.'}, {'measure': 'Change in Muscle Strength', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Muscle strength will be tested on the right quadriceps femoris (upper leg) using an isokinetic dynamometer.'}, {'measure': 'Change in Muscle Size', 'timeFrame': 'Baseline and 8 Weeks', 'description': 'Muscle size of the right quadriceps femoris (upper leg) will be determined using ultrasonography (ultrasound).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '40977987', 'type': 'DERIVED', 'citation': "Smith AN, Sullivan DK, Morris JK, Carbuhn AF, Herda TJ, Taylor MK. Eight weeks of creatine monohydrate supplementation is associated with increased muscle strength and size in Alzheimer's disease: data from a single-arm pilot study. Front Nutr. 2025 Sep 4;12:1670641. doi: 10.3389/fnut.2025.1670641. eCollection 2025."}, {'pmid': '40395689', 'type': 'DERIVED', 'citation': "Smith AN, Choi IY, Lee P, Sullivan DK, Burns JM, Swerdlow RH, Kelly E, Taylor MK. Creatine monohydrate pilot in Alzheimer's: Feasibility, brain creatine, and cognition. Alzheimers Dement (N Y). 2025 May 19;11(2):e70101. doi: 10.1002/trc2.70101. eCollection 2025 Apr-Jun."}, {'pmid': '38414003', 'type': 'DERIVED', 'citation': "Taylor MK, Burns JM, Choi IY, Herda TJ, Lee P, Smith AN, Sullivan DK, Swerdlow RH, Wilkins HM. Protocol for a single-arm, pilot trial of creatine monohydrate supplementation in patients with Alzheimer's disease. Pilot Feasibility Stud. 2024 Feb 27;10(1):42. doi: 10.1186/s40814-024-01469-5."}]}, 'descriptionModule': {'briefSummary': "By doing this study, researchers hope to see if creatine monohydrate is a helpful treatment for people with Alzheimer's disease.", 'detailedDescription': "Alzheimer's disease is a progressive brain disorder that causes memory and thinking problems. Current medications may temporarily help with symptoms but cannot stop the disease from getting worse. As such, new treatments that slow or stop the disease from progressing are needed.\n\nThere is some evidence from animal studies that taking creatine monohydrate may improve thinking in Alzheimer's disease and be good for brain health. However, no studies have looked at creatine monohydrate supplementation in humans with Alzheimer's.\n\nCreatine monohydrate is a dietary supplement regulated by the FDA. This is a study that will test if taking creatine monohydrate may be a helpful treatment for people with Alzheimer's disease. In this study, investigators will will evaluate:\n\n1. Whether persons with Alzheimer's disease are able to easily take creatine monohydrate for 8 weeks.\n2. Whether creatine monohydrate affects thinking function in people with Alzheimer's Disease.\n3. Whether creatine monohydrate affects certain biochemicals in the brain and body.\n4. Whether creatine monohydrate improves muscle size and strength."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed cognitive impairment due to Alzheimer's disease\n* Agreed cooperation from a study partner\n* Speaks English as primary language\n* Age 60 to 90\n* Stable medication for ≥30 days\n* BMI ≥ 20.0kg/m2\n\nExclusion Criteria:\n\n* Insulin-requiring diabetes, cancer requiring chemotherapy or radiation within the past 5 years, or recent cardiac event (i.e., heart attack, etc.)\n* Other neurodegenerative disease\n* Ongoing renal disorder or abnormal renal or liver function\n* Unable to undergo MRI\n* Clinical trial or investigational drug or therapy participation within 30 days of the screening visit\n* Non-English speakers\n* Inability to perform strength testing\n* Weight \\> 350 lbs."}, 'identificationModule': {'nctId': 'NCT05383833', 'acronym': 'CABA', 'briefTitle': "Creatine to Augment Bioenergetics in Alzheimer's", 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': "Creatine to Augment Bioenergetics in Alzheimer's", 'orgStudyIdInfo': {'id': '148507'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Creatine Monohydrate Arm', 'description': 'This study a single arm intervention. All participants will receive 20 grams of creatine monohydrate daily for the whole intervention (8 weeks).', 'interventionNames': ['Dietary Supplement: Creatine Monohydrate']}], 'interventions': [{'name': 'Creatine Monohydrate', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will take 20 grams of creatine monohydrate daily for 8 weeks.The 20 grams will be divided into two equal 10 gram doses that will be stirred into a beverage. One 10 gram dose will be taken in the morning and the other 10 gram dose in evening.', 'armGroupLabels': ['Creatine Monohydrate Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Matthew Taylor, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': "Alzheimer's Association", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Matthew Taylor', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}