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| ID | Type | Description | Link |
|---|---|---|---|
| 188505 | Registry Identifier | Office of Clinical Trials - Health Canada |
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| Name | Class |
|---|---|
| Ultragenyx Pharmaceutical Inc | INDUSTRY |
| Fonds de la Recherche en Santé du Québec | OTHER_GOV |
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BEAT7-001 is a single group study (supplementation). Using a multi-modal brain imaging portfolio, this study will assess whether brain energy metabolism (glucose and ketones), structure or functional connectivity change in older people with frontal glucose hypometabolism after 28 days on an oral dose of 1 g/kg/day of triheptanoin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triheptanoin | Experimental | Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POST Triheptanoin | Drug | The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Change in Brain Glucose Uptake | Global change (average of cortex) in brain glucose uptake as measured by 18F-FDG PET scans PRE vs POST 28±2 days of supplementation | 28±2 days |
| Global Change in Brain Ketone Uptake | Global change in brain ketone uptake as measured by 11C-acetoacetate PET scans | 28±2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Brain Volumes | Structural imaging by T1-weighted MRI to measure brain volume | 28±2 days |
| Change in Cerebral Blood Flow | change in cerebral blood flow measured by arterial spin labeling (ASL) and calculated using a one-compartment model (average cortex) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Cunnane, Ph.D. | Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS) | Sherbrooke | Quebec | J1H4C4 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Triheptanoin | Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol. POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack. control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Only the 11 participants which have completed the intervention are included in the baseline analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Triheptanoin | Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol. POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack. control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Global Change in Brain Glucose Uptake | Global change (average of cortex) in brain glucose uptake as measured by 18F-FDG PET scans PRE vs POST 28±2 days of supplementation | Posted | Mean | Standard Deviation | μmol/100 g/min | 28±2 days |
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During 4 week supplementation period
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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 | Triheptanoin | Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol. POST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack. control PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| severe stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Cunnane | University of Sherbrooke | 819-780-2220 | 45670 | stephen.cunnane@usherbrooke.ca |
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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 | Apr 4, 2017 | Feb 14, 2019 | Prot_SAP_000.pdf |
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The participant will receive THN treatment, compared to PRE supplementation condition.
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|
| 28±2 days |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Glucose uptake changes estimated by comparing participants' measurements to imaging standards of hea | Mean | Standard Deviation | % of difference compare to young control |
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| Education | Mean | Standard Deviation | years |
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| Montreal Cognitive Assessment (MoCA) | Assessment of cognition. The scale ranges from 0 to 30 points, with higher scores representing better cognitive ability | Mean | Standard Deviation | scores on a scale |
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| body mass index | Mean | Standard Deviation | kg/m^2 |
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| Primary | Global Change in Brain Ketone Uptake | Global change in brain ketone uptake as measured by 11C-acetoacetate PET scans | Posted | Mean | Standard Deviation | μmol/100 g/min | 28±2 days |
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| Secondary | Change in Brain Volumes | Structural imaging by T1-weighted MRI to measure brain volume | data was not available for 2 participants | Posted | Mean | Standard Deviation | ml/100 g/ min | 28±2 days |
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| Secondary | Change in Cerebral Blood Flow | change in cerebral blood flow measured by arterial spin labeling (ASL) and calculated using a one-compartment model (average cortex) | Posted | Mean | Standard Deviation | ml/100 g/ min | 28±2 days |
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| 0 |
| 15 |
| 0 |
| 15 |
| 1 |
| 15 |
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| Title | Measurements |
|---|---|
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| Amygdala POST supplementation |
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| Thalamus PRE |
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| Thalamus POST suplementation |
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| Caudate PRE |
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| Caudate POST supplementation |
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