Alzheimer's DiseaseMINT-01NCT02912936
A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease
A study testing Ketogenic medium chain triglyceride drink (MCT drink) in people with Alzheimer's Disease and Primary Progressive Non-fluent Aphasia, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this study is to determine safety, tolerability, and pharmacokinetics/dynamics of a ketogenic dietary supplement containing medium chain triglycerides (MCTs) in patients with Alzheimer disease (AD). Novel imaging and laboratory biomarkers in response to this intervention will also be explored. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Alzheimer's Disease, Primary Progressive Non-fluent Aphasia, Frontotemporal Dementia (FTD)
- What is being tested?
- Ketogenic medium chain triglyceride drink (MCT drink)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to 1 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of mild-moderate Alzheimer disease (AD)
- Mini-Mental State Examination (MMSE) 16-26
- Study partner available who has frequent contact with the participant
- Good visual and auditory acuity for neuropsychological testing
- Education including completion of at least six grades
- Must read and speak English fluently
- Antidepressants permitted, if stable for 4 weeks prior to screening (and participant is not currently depressed and does not have a history of major depression within the past 1 year)
- Cholinesterase inhibitors permitted, if stable for 12 weeks prior to screening
Who cannot join
- Any significant neurologic disease other than AD
- History of Diabetes Mellitus type I or II
- Any contraindications to MRI or PET studies
- Major depression, bipolar disorder as described within the past 1 year.
- History of schizophrenia
- History of alcohol or substance abuse or dependence within the past 2 years
Show all 36Show fewer
- Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol
- Current use of specific psychoactive medications
- Investigational amyloid lowering therapies are prohibited two months prior to screening and for the duration of the trial. Other investigational agents are prohibited one month prior to screening and for the duration of the trial.
- History of brain cancer
- For FTD-nfvPPA substudy Inclusion Criteria
- Dx of nonfluent/agrammatic variant primary progressive aphasia
- Older than 19 years
- Stability of permitted medications for 4 weeks. In particular, subjects may:
- Take stable doses of antidepressants (if they are not currently depressed or do not have a history of major depression within the past 1 year).
- Washout from psychoactive medication for at least 4 weeks prior to screening.
- Cholinesterase inhibitors are allowable if stable for 12 weeks prior to the screening visit.
- Study partner is available who has frequent contact with the subject (e.g. an average of 8 hours per week or more), and can accompany the subject to all clinic visits for the duration of the protocol.
- Females are not pregnant, lactating, or of childbearing potential (i.e. women must be two years post-menopausal or surgically sterile).
- PET scan consistent with FTD (showing frontal hypoperfusion +/- temporal hypoperfusion)
- MRI consistent with FTD/PNFA
- Education including completion of at least six grades
- Must read and speak English fluently
- Any significant neurologic disease other than FTD, such as Alzheimer disease, progressive supranuclear palsy, Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, space occupying brain lesion, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities
- History of Diabetes Mellitus type I or II; Hb A1C > 6.0
- Subjects that have any contraindications to MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, cardiac pacemaker will be excluded from the study, or known bleeding disorder.
- Major depression, bipolar disorder, or schizophrenia as described in DSM-IV within the past 1 year. Psychotic features, agitation or behavioral problems within 3 months, which could lead to difficulty complying with the protocol.
- Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol.
- Current use (sporadic or chronic, within 30 days of screening) of specific psychoactive medications (e.g. typical neuroleptics, narcotic analgesics, anti-Parkinsonian medications, systemic corticosteroids, or medications with significant central anticholinergic activity, etc.)
- Current use of warfarin or other anti-coagulants.
- Current or recent participation in any procedures involving radioactive agents, including current, past, or anticipated exposure to radiation in the workplace, such that the total radiation dose exposure to the subject in a given year would exceed the limits of annual and total dose commitment set forth in the Health Canada guidelines
- AST, ALT, total bilirubin >1.5 times the upper limit of normal;
- Serum creatinine >1.5 times the upper limit of normal
- Has a clinically significant laboratory abnormality, in the opinion of the one of the principal investigators.
- Regular use of MCT products within 30 days of screening. (eg coconut oil, palm oil, coconut milk)
- History of brain cancer
Trial locations and contacts
1 site in 1 country.
Canada1 site
Djavad Mowafaghian Centre for Brain Health
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: A Medium Chain Triglyceride INTervention for Alzheimer Disease (A MINT for AD)
The purpose of this study is to determine safety, tolerability, and pharmacokinetics/dynamics of a ketogenic dietary supplement containing medium chain triglycerides (MCTs) in patients with Alzheimer disease (AD). Novel imaging and laboratory biomarkers in response to this intervention will also be explored. In addition, a sub-study was added to the UBC-approved protocol on November 29, 2016, prior to enrollment of the first FTD participant in April 2017. The FTD sub-study was designed as a pilot study to evaluate the safety and tolerability of MCT supplementation in participants with nonfluent/agrammatic variant primary progressive aphasia (nfvPPA).
- Conditions
- Alzheimer's Disease, Primary Progressive Non-fluent Aphasia, Frontotemporal Dementia (FTD)
- Being tested
- Ketogenic medium chain triglyceride drink (MCT drink), Placebo
- Keywords
- medium chain triglyceride, MCT, coconut oil, MRI, PET, ketones
- Medical subject headings
- Alzheimer Disease, Primary Progressive Nonfluent Aphasia, Frontotemporal Dementia, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketogenic medium chain triglyceride drink (MCT drink)Dietary supplement
10 days supplementation with the MCT drink. Participants in dose group 1 will be assigned to 10 g per day, those in dose group 2 will be assigned 20 g per day, those in dose group 3 will be assigned 30 g per day, those in dose group 4 will be assigned 40 g per day, and those in dose group 5 will be assigned 50 g per day. The drink will be taken in the morning and evening. Participants will be enrolled 8 per group in ascending order.
PlaceboDietary supplement
10 days supplementation with the placebo drink. Participants in dose group 1 will be assigned to 10 g per day, those in dose group 2 will be assigned 20 g per day, those in dose group 3 will be assigned 30 g per day, those in dose group 4 will be assigned 40 g per day, and those in dose group 5 will be assigned 50 g per day. The drink will be taken in the morning and evening. Participants will be enrolled 8 per group in ascending order.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic medium chain triglyceride drink | Experimental | Lactose-free skim milk drink containing 25 g of MCT oil per 250 ml. Receives: Dietary Supplement: Ketogenic medium chain triglyceride drink (MCT drink) |
| Placebo | Placebo comparator | Lactose-free skim milk drink containing high-oleic sunflower oil in the equivalent amount of energy as the active arm. Receives: Dietary Supplement: Placebo |
| MCT first, then placebo (Sequence A) | Experimental | Participants received SCCF-3012 (ketogenic medium-chain triglyceride emulsion, 15 g twice daily = 30 g/day total) for 3 months during Period 1, followed by placebo (high-oleic sunflower oil, energy-matched) for 3 months during Period 2. No washout period between phases. Applies to MINT-FTD sub-study cohort only. Receives: Dietary Supplement: Ketogenic medium chain triglyceride drink (MCT drink); Dietary Supplement: Placebo |
| Placebo first, then MCT (Sequence B) | Experimental | Participants received placebo (high-oleic sunflower oil, energy-matched) for 3 months during Period 1, followed by SCCF-3012 (ketogenic medium-chain triglyceride emulsion, 15 g twice daily = 30 g/day total) for 3 months during Period 2. No washout period between phases. Applies to MINT-FTD sub-study cohort only. Receives: Dietary Supplement: Ketogenic medium chain triglyceride drink (MCT drink); Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events, serious adverse events
Measured: From baseline to day 10 of intervention
Plasma ketone concentrations in response to ascending dose of MCT
Plasma ketone concentrations of betahydroxybutyrate (BHB) and acetoacetate (AcAc) will be measured in response to MCT dosing from 10-50 grams daily.
Measured: Day 10 of intervention at 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, and 6 hours post MCT dose
Safety and tolerability of SCCF-3012
Incidence of treatment-emergent adverse events, serious adverse events, and laboratory parameter changes during 3 months of continuous SCCF-3012 dosing at 30 g/day (15 g BID) in participants with nonfluent/agrammatic variant primary progressive aphasia (nfvPPA). Adverse events tabulated by severity (mild/moderate/severe) and relatedness to study intervention (unlikely/possible/probable/likely). Tolerability assessed by the proportion of participants able to complete 3 months of continuous dosing at the target dose without intervention-related discontinuation.
Measured: Baseline to Month 6
Pharmacodynamic ketone response
Plasma β-hydroxybutyrate (BHB) concentration in FTD-nfvPPA participants at pre-dose, 1 hour, and 4 hours following ingestion of the study drink, measured at the end of each 3-month phase. Primary pharmacodynamic endpoint is the 4-hour post-dose plasma BHB at the end of the MCT phase.
Measured: Baseline, Month 3, Month 6 (each at pre-dose, 1 hour, and 4 hours post-dose)
Secondary outcomes (4)
Area under the plasma concentration versus time curve (AUC) of MCT
To determine the MCT plasma concentration at stated time points in response to MCT dosing from 10-50 grams daily.
Measured: Day 10 of intervention at 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, and 6 hours post MCT dose
Change in language function (WAB-R Part 1)
For FTD-nfvPPA, Western Aphasia Battery-Revised Part I Aphasia Quotient (AQ; range 0-100, higher = better language function). Administered by a blinded examiner. Within-subject change analyzed as end-of-MCT-phase AQ minus end-of-placebo-phase AQ.
Measured: Baseline, Month 3, Month 6
Change in global functional status (FTLD-CDR-SB)
Frontotemporal Lobar Degeneration Clinical Dementia Rating Sum of Boxes (FTLD-CDR-SB), extended from the standard CDR with language and behaviour modules. Range 0-24, with higher scores indicating greater impairment. Within-subject change analyzed as end-of-MCT-phase minus end-of-placebo-phase.
Measured: Baseline, Month 3, Month 6
Global clinical impression of change (CGIC)
Clinician Global Impression of Change (7-point scale: 1 = very much improved to 7 = very much worse), rated by a study clinician blinded to treatment allocation. At each follow-up visit, rating reflects change relative to the immediately preceding assessment (3-month phase) and is attributable to the treatment received during that phase.
Measured: Month 3, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion4 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- FTD-nfvPPA substudy: crossover pilot design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Sherbrooke
- Responsible party
- Principal investigator, Haakon Nygaard, University of British Columbia
- Investigators
- Haakon Nygaard, MD, PhD, Principal investigator, University of British ColumbiaHoward Feldman, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912936
- Sponsor's protocol ID
- H15-02537
- Acronym
- MINT-01
- Status last verified
- Apr 2026
- First submitted
- 13 Jul 2016
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Medium Chain Triglyceride INTervention for Alzheimer Disease (A MINT for AD)
- ClinicalTrials.gov ID
- NCT02912936
- Acronym / sponsor ID
- MINT-01 / H15-02537
- Conditions
- Alzheimer's Disease, Primary Progressive Non-fluent Aphasia, Frontotemporal Dementia (FTD)
- Keywords
- medium chain triglyceride, MCT, coconut oil, MRI, PET, ketones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Université de Sherbrooke
- Study start
- Sep 2016 (actual)
- Primary completion
- 4 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 23 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine safety, tolerability, and pharmacokinetics/dynamics of a ketogenic dietary supplement containing medium chain triglycerides (MCTs) in patients with Alzheimer disease (AD). Novel imaging and laboratory biomarkers in response to this intervention will also be explored. In addition, a sub-study was added to the UBC-approved protocol on November 29, 2016, prior to enrollment of the first FTD participant in April 2017. The FTD sub-study was designed as a pilot study to evaluate the safety and tolerability of MCT supplementation in participants with nonfluent/agrammatic variant primary progressive aphasia (nfvPPA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- FTD-nfvPPA substudy: crossover pilot design
| Arm | Type | Receives |
|---|---|---|
| Ketogenic medium chain triglyceride drink | Experimental | Dietary Supplement: Ketogenic medium chain triglyceride drink (MCT drink)Lactose-free skim milk drink containing 25 g of MCT oil per 250 ml. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboLactose-free skim milk drink containing high-oleic sunflower oil in the equivalent amount of energy as the active arm. |
| MCT first, then placebo (Sequence A) | Experimental | Dietary Supplement: Ketogenic medium chain triglyceride drink (MCT drink), Dietary Supplement: PlaceboParticipants received SCCF-3012 (ketogenic medium-chain triglyceride emulsion, 15 g twice daily = 30 g/day total) for 3 months during Period 1, followed by placebo (high-oleic sunflower oil, energy-matched) for 3 months during Period 2. No washout period between phases. Applies to MINT-FTD sub-study cohort only. |
| Placebo first, then MCT (Sequence B) | Experimental | Dietary Supplement: Ketogenic medium chain triglyceride drink (MCT drink), Dietary Supplement: PlaceboParticipants received placebo (high-oleic sunflower oil, energy-matched) for 3 months during Period 1, followed by SCCF-3012 (ketogenic medium-chain triglyceride emulsion, 15 g twice daily = 30 g/day total) for 3 months during Period 2. No washout period between phases. Applies to MINT-FTD sub-study cohort only. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of mild-moderate Alzheimer disease (AD)
- Mini-Mental State Examination (MMSE) 16-26
- Study partner available who has frequent contact with the participant
- Good visual and auditory acuity for neuropsychological testing
- Education including completion of at least six grades
Key exclusion criteria (36 listed)
- Any significant neurologic disease other than AD
- History of Diabetes Mellitus type I or II
- Any contraindications to MRI or PET studies
- Major depression, bipolar disorder as described within the past 1 year.
- History of schizophrenia
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 |
|---|---|---|
| Ketogenic medium chain triglyceride drink (MCT drink)10 days supplementation with the MCT drink. Participants in dose group 1 will be assigned to 10 g per day, those in dose group 2 will be assigned 20 g per day, those in dose group 3 will be assigned 30 g per day, those in dose group 4 will be assigned 40 g per day, and those in dose group 5 will be assigned 50 g per day. The drink will be taken in the morning and evening. Participants will be enrolled 8 per group in ascending order. | Dietary supplement | Ketogenic medium chain triglyceride drink, MCT first, then placebo (Sequence A), Placebo first, then MCT (Sequence B) |
| Placebo10 days supplementation with the placebo drink. Participants in dose group 1 will be assigned to 10 g per day, those in dose group 2 will be assigned 20 g per day, those in dose group 3 will be assigned 30 g per day, those in dose group 4 will be assigned 40 g per day, and those in dose group 5 will be assigned 50 g per day. The drink will be taken in the morning and evening. Participants will be enrolled 8 per group in ascending order. | Dietary supplement | MCT first, then placebo (Sequence A), Placebo, Placebo first, then MCT (Sequence B) |
Primary outcome
Number of participants with adverse events, serious adverse events
Time frame: From baseline to day 10 of intervention
Plasma ketone concentrations in response to ascending dose of MCT
Time frame: Day 10 of intervention at 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, and 6 hours post MCT dose
Plasma ketone concentrations of betahydroxybutyrate (BHB) and acetoacetate (AcAc) will be measured in response to MCT dosing from 10-50 grams daily.
Safety and tolerability of SCCF-3012
Time frame: Baseline to Month 6
Incidence of treatment-emergent adverse events, serious adverse events, and laboratory parameter changes during 3 months of continuous SCCF-3012 dosing at 30 g/day (15 g BID) in participants with nonfluent/agrammatic variant primary progressive aphasia (nfvPPA). Adverse events tabulated by severity (mild/moderate/severe) and relatedness to study intervention (unlikely/possible/probable/likely). Tolerability assessed by the proportion of participants able to complete 3 months of continuous dosing at the target dose without intervention-related discontinuation.
Pharmacodynamic ketone response
Time frame: Baseline, Month 3, Month 6 (each at pre-dose, 1 hour, and 4 hours post-dose)
Plasma β-hydroxybutyrate (BHB) concentration in FTD-nfvPPA participants at pre-dose, 1 hour, and 4 hours following ingestion of the study drink, measured at the end of each 3-month phase. Primary pharmacodynamic endpoint is the 4-hour post-dose plasma BHB at the end of the MCT phase.
4 secondary outcomes
Area under the plasma concentration versus time curve (AUC) of MCT
Time frame: Day 10 of intervention at 0.5, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, and 6 hours post MCT dose
Change in language function (WAB-R Part 1)
Time frame: Baseline, Month 3, Month 6
Change in global functional status (FTLD-CDR-SB)
Time frame: Baseline, Month 3, Month 6
Global clinical impression of change (CGIC)
Time frame: Month 3, Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
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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.
Haakon Nygaard, MD, PhD principal investigator
University of British Columbia
Howard Feldman, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketogenic medium chain triglyceride drink (MCT drink) in people with Alzheimer's Disease and Primary Progressive Non-fluent Aphasia, run by University of British Columbia 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 8 inclusion and 36 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 Apr 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with adverse events, serious adverse events (time frame: From baseline to day 10 of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2026.