Frontal Lobe HypometabolismPhase 1/2BEAT7NCT02679235

Brain Energy and Aging With Triheptanoin

A Phase 1/2 study testing POST Triheptanoin in people with Frontal Lobe Hypometabolism, run by Université de Sherbrooke at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Frontal Lobe Hypometabolism
What is being tested?: POST Triheptanoin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteCanada
Study dates: Apr 2016to 8 Aug 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Men and women ≥65 years old;
Score ≥26/30 on the Montreal Cognitive Assessment; -≥10% lower brain glucose uptake in the frontal cortex as determined by PET imaging.

Who cannot join

Score <26/30 on the Montreal Cognitive Assessment;
Medications likely to affect the primary cognitive outcome;
Medical or psychiatric conditions that could interfere with study participation (Peterson et al. 2005);
Fasting plasma glucose ≥7.0 mM (to avoid recruiting diabetics or pre-diabetics, both of which are risk factors for cognitive impairment in older persons (Mortimer et al. 2010) and also inhibit ketogenesis (Fukao et al. 2004);
Clinically-significant gastro-intestinal disease/conditions;
Clinically-significant liver disease/dysfunction : ALT ≥37 UI/L, AST ≥36 UI/L, Total bilirubin ≥26 μmol/L;

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Clinically-significant renal disease/dysfunction : creatinine ≥92 μmol/L, glomerular filtration rate <60 ml/min/1.73 m2 or >90 ml/min/1.73 m2;
Clinically-significant cardiac disease/conditions;
Clinically-significant abnormal coagulation laboratory results or coagulation disorders at screening;
Poorly controlled dyslipidemia (total cholesterol ≥6.2 mmol/L or triglycerides ≥2.20 mmol/L)
Hypertension: ≥140/90 mmHg;
Substance abuse;
Already on MCT supplementation;
Visual or hearing impairment impeding comprehension;
Non-French speaking;
Any condition with life expectancy less than 5 years;
Institutionalized or intending to move out of area within 1 year;
Participation in other intervention trials.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
Sherbrooke, Quebec, J1H4C4

Other trials in Canada

About this study

Official title: Brain Energy and Aging With Triheptanoin: The BEAT7 Study

Conditions: Frontal Lobe Hypometabolism
Being tested: POST Triheptanoin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

POST TriheptanoinDrug
Also called POST THN
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.

Study groups in NCT02679235
Study group	Role	What they receive
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. Receives: Drug: POST Triheptanoin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 28±2 days
Global Change in Brain Ketone Uptake
Global change in brain ketone uptake as measured by 11C-acetoacetate PET scans
Measured: 28±2 days

Secondary outcomes (2)

Change in Brain Volumes
Structural imaging by T1-weighted MRI to measure brain volume
Measured: 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)
Measured: 28±2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 20168 Aug 2018

First posted10 Feb 2016 (estimated)
Study startApr 2016
Primary completion8 Aug 2018
Study completion8 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Frontal Lobe HypometabolismStudies of the same condition, open and under way.
More trials run by Université de SherbrookeThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: The participant will receive THN treatment, compared to PRE supplementation condition.
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02679235
Sponsor's protocol ID: 2016-617
Other IDs: 188505
Acronym: BEAT7
Status last verified: Jul 2020
First submitted: 1 Feb 2016
Last updated: 23 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain Energy and Aging With Triheptanoin: The BEAT7 Study
ClinicalTrials.gov ID: NCT02679235
Acronym / sponsor ID: BEAT7 / 2016-617
Conditions: Frontal Lobe Hypometabolism
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Université de SherbrookeUniversity, hospital or other
Collaborators: Ultragenyx Pharmaceutical Inc, Fonds de la Recherche en Santé du Québec
Study start: Apr 2016 (actual)
Primary completion: 8 Aug 2018 (actual)
Study completion: 8 Aug 2018 (actual)
First posted: 10 Feb 2016 (estimated)
Results: Posted 15 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The participant will receive THN treatment, compared to PRE supplementation condition.

Arm	Type	Receives
Triheptanoin	Experimental	Drug: POST TriheptanoinParticipant 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.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (2 listed)

Men and women ≥65 years old;
Score ≥26/30 on the Montreal Cognitive Assessment; -≥10% lower brain glucose uptake in the frontal cortex as determined by PET imaging.

Key exclusion criteria (18 listed)

Score <26/30 on the Montreal Cognitive Assessment;
Medications likely to affect the primary cognitive outcome;
Medical or psychiatric conditions that could interfere with study participation (Peterson et al. 2005);
Fasting plasma glucose ≥7.0 mM (to avoid recruiting diabetics or pre-diabetics, both of which are risk factors for cognitive impairment in older persons (Mortimer et al. 2010) and also inhibit ketogenesis (Fukao et al. 2004);
Clinically-significant gastro-intestinal disease/conditions;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
POST TriheptanoinAlso: POST THNThe 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.	Drug	Triheptanoin

Primary outcome

Global Change in Brain Glucose Uptake
Time frame: 28±2 days
Global change (average of cortex) in brain glucose uptake as measured by 18F-FDG PET scans PRE vs POST 28±2 days of supplementation
Global Change in Brain Ketone Uptake
Time frame: 28±2 days
Global change in brain ketone uptake as measured by 11C-acetoacetate PET scans

2 secondary outcomes

Change in Brain Volumes
Time frame: 28±2 days
Change in Cerebral Blood Flow
Time frame: 28±2 days

Results and safety

Results posted to the registry on 15 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Triheptanoin	15	11

Primary outcome: Global Change in Brain Glucose Uptake

Time frame: 28±2 days. Mean (Standard Deviation). Unit: μmol/100 g/min

Measure	Triheptanoin n = 11
PRE	30.3 (1.7)
POST supplementation	30.4 (3.4)

Primary outcome: Global Change in Brain Ketone Uptake

Time frame: 28±2 days. Mean (Standard Deviation). Unit: μmol/100 g/min

Measure	Triheptanoin n = 11
PRE	0.58 (0.4)
POST supplementation	0.26 (0.2)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: During 4 week supplementation period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Triheptanoin	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephen Cunnane, Ph.D. principal investigator

Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing POST Triheptanoin in people with Frontal Lobe Hypometabolism, run by Université de Sherbrooke at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global Change in Brain Glucose Uptake (time frame: 28±2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02679235.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.