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Withdrawal of funding
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| Name | Class |
|---|---|
| Farmer Family Foundation | UNKNOWN |
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Small exploratory open-label pilot study to assess supplementation of a ketone ester (KetoneAid) as a potential therapy for persons with Parkinson disease (PD), Parkinson Disease Dementia/Lewy Body Dementia (PDD/LBD), and healthy controls.
The overarching goal of this study is to investigate glucose metabolic, cognitive, clinical and imaging changes in persons with PD and PDD/LBD before and after a month supplementation of a ketone ester (KetoneAid) in a small open label exploratory clinical trial. Positive findings in this small exploratory pilot trial may support future target engagement studies of ketone supplementation in PD and normal adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson Disease | Experimental | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary. |
|
| Parkinson Disease Dementia/Lewy Body Dementia | Experimental | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) TID as tolerated. KE dose will be titrated down to a tolerated level if necessary. |
|
| Healthy Controls | Experimental | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) TID as tolerated. KE dose will be titrated down to a tolerated level if necessary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate | Dietary Supplement | Ketone ester (KE) dietary supplement (KetoneAid) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Metabolism | Continuous glucose meter 7-10-day average glucose readings before/after open-label treatment with the ketone ester in patients with PD, Parkinson's disease dementia/Lewy body dementia, and normal controls. Healthy fasting blood glucose ranges from 70 to 99 milligrams per deciliter (mg/dL), with a healthy maximum of 180 mg/dL within 2 hours of eating meals. | Pre and post approximately 30 days of intervention |
| Clinical Dementia Rating Scale Score | The clinical dementia rating scale is a measure of functional and cognitive performance relevant to dementia. It is scored from 0 (normal) to 3 (severe dementia). The clinical dementia rating scale will be assessed in patients with Parkinson's disease, Parkinson's disease dementia/Lewy body dementia, and healthy controls before and after open-label treatment with the ketone ester. | Pre and post approximately 30 days of intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolaas Bohnen, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Domino's Farms | Ann Arbor | Michigan | 48105 | United States | ||
| University Hospital |
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16 participants were enrolled in the study. There were no withdrawals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Parkinson Disease | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) |
| FG001 | Parkinson Disease Dementia/Lewy Body Dementia | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) TID as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) |
| FG002 | Healthy Controls | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) TID as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Parkinson Disease | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glucose Metabolism | Continuous glucose meter 7-10-day average glucose readings before/after open-label treatment with the ketone ester in patients with PD, Parkinson's disease dementia/Lewy body dementia, and normal controls. Healthy fasting blood glucose ranges from 70 to 99 milligrams per deciliter (mg/dL), with a healthy maximum of 180 mg/dL within 2 hours of eating meals. | 13 of the 16 participants completed continuous glucose monitoring. The remaining 3 participants did not complete continuous glucose monitoring due to device availability and ability to understand instructions. Healthy control sample size (n=2) was not sufficient to perform statistical analysis for that group. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Pre and post approximately 30 days of intervention |
|
For all subjects, data was collected during the 30 +/- 7 days of tributyrin intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parkinson Disease | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment | Unrelated, unexpected AE |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicolaas Bohnen, MD, PhD | University of Michigan | 734-936-1168 | nbohnen@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2024 | Sep 19, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 15, 2023 | Nov 1, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020961 | Lewy Body Disease |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| BG001 | Parkinson Disease Dementia/Lewy Body Dementia | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) TID as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) |
| BG002 | Healthy Controls | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) TID as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Education | Mean | Standard Deviation | years |
|
| Modified Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRSIII) | The Modified Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3 is a clinician-administered motor exam consisting of 18 items to evaluate the motor symptom severity in Parkinson's disease. Total scores range from 0 to 132, with higher scores indicating higher severity of motor symptoms. MDS-UPDRS Part 3 scores of 32 and below are typically considered mild, 33-58 is moderate, and 59 and above considered severe. | Mean | Standard Deviation | units on a scale |
|
| Montreal Cognitive Assessment (MoCA) | The Montreal Cognitive Assessment (MoCA) is used for detection of mild cognitive impairment. It assesses short-term memory, visuospatial abilities, executive functioning, attention, language, and orientation. Scores range from 0 to 30, with low scores indicating more cognitive impairment. Scores of 26 and above indicate normal cognitive performance, 18-25 indicate mild impairment, 10-17 indicate moderate impairment, and 0-9 indicate severe impairment. | Mean | Standard Deviation | units on a scale |
|
| Parkinson's Disease Cognitive Rating Scale (PDCRS) | The Parkinson's Disease Cognitive Rating Scale (PDCRS) evaluates cognition in Parkinson's disease. Scores range from 0-134 with lower scores indicating increased cognitive impairment. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Parkinson Disease Dementia/Lewy Body Dementia | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) |
| OG002 | Healthy Controls | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) |
|
|
|
| Primary | Clinical Dementia Rating Scale Score | The clinical dementia rating scale is a measure of functional and cognitive performance relevant to dementia. It is scored from 0 (normal) to 3 (severe dementia). The clinical dementia rating scale will be assessed in patients with Parkinson's disease, Parkinson's disease dementia/Lewy body dementia, and healthy controls before and after open-label treatment with the ketone ester. | All participants completed CDR before and after intervention. There was no change in CDR scores in the Parkinson's disease group, and the Healthy Control group had insufficient sample size (n = 2) to perform any statistical analysis. | Posted | Mean | Standard Deviation | score on a scale | Pre and post approximately 30 days of intervention |
|
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Parkinson Disease Dementia/Lewy Body Dementia | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) | 0 | 10 | 0 | 10 | 8 | 10 |
| EG002 | Healthy Controls | Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) | 0 | 2 | 0 | 2 | 1 | 2 |
|
| Ear Infection | Ear and labyrinth disorders | Systematic Assessment | Unrelated, unexpected AE |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment | Unrelated, unexpected AE |
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| Confusion | Psychiatric disorders | Systematic Assessment | Possibly related, expected AE |
|
| Freezing of Gait | Nervous system disorders | Systematic Assessment | Unrelated, unexpected AE |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Possibly related, expected AE |
|
| Hallucinations | Psychiatric disorders | Systematic Assessment | Unrelated, unexpected AE |
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| Headache | Nervous system disorders | Systematic Assessment | Possibly related, expected AE |
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| Heartburn | Gastrointestinal disorders | Systematic Assessment | Possibly related, expected AE |
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| Lightheadedness | Metabolism and nutrition disorders | Systematic Assessment | Possibly related, expected AE |
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| Low energy | General disorders | Systematic Assessment | Unrelated, unexpected AE |
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| Low glucose | Metabolism and nutrition disorders | Systematic Assessment | Possibly related, expected AE |
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| Discomfort in Scanner | Injury, poisoning and procedural complications | Systematic Assessment | Related, expected AE |
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| Sleep changes | General disorders | Systematic Assessment | Possibly related, expected AE |
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| Muscle soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment | Possibly related, expected AE |
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| Stomach ache | Gastrointestinal disorders | Systematic Assessment | Possibly related, expected AE |
|
| Throat irritation | General disorders | Systematic Assessment | Possibly related, expected AE |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D003704 | Dementia |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
|