Alzheimer's DiseasePhase 2/3NCT01883648
Study to Evaluate Coconut Oil for Alzheimer's Disease
A Phase 2/3 study testing Coconut Oil Beverage in people with Alzheimer's Disease, run by University of South Florida at 1 site in United States.
Trial summary
This is a randomized, cross over study to determine the efficacy of coconut oil in subjects with mild to moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Coconut Oil Beverage
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 1 Feb 2017
- Phase
- Phase 2/3
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 55 to 90 years with a diagnosis of mild to moderate Alzheimer's disease
- Informed consent signed and dated by subject (or legally authorized representative).
- Subjects must have a study partner must also consent to participate in the study, who they spend at least 10 hours/week with during the study. The study partner must attend applicable clinic visits and provide information about the subject.
- Subject must have a screening Mini-Mental State Examination score of 16-26.
- Subjects must have a Rosen Modified Hachinski Ischemic score of ≤4.
- Subject must undergo ApoE genetic laboratory testing at the baseline visit.
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- Subject must be willing and able to take study medication (or placebo) for the duration of the study.
- Subject must be stable on all memory enhancing medications including cholinesterase inhibitors (including donepezil, rivastigmine, and galantamine) and NMDA antagonist (memantine) for at least 3 months prior to screening and agree not to change these medications during the course of their participation, unless medically necessary.
- Subject must be stable on all memory enhancing nonprescription supplements (including gingko biloba, huperzine, resveratrol, or docosahexaenoic acid) for at least 3 months prior to screening and agree not to change these medications during the course of their participation.
- As judged by Investigator, the subject and study partner will be compliant and have a high probability of completing the study, including all scheduled evaluations and required tests.
- Be fluent in English.
Who cannot join
- Has significant neurological or medical disease, other than AD, that may affect cognition, for example, history or evidence of hydrocephalus, or uncontrolled hypo- or hyperthyroidism.
- Current, clinically significant major psychiatric disorder (eg, major depressive disorder) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSMIV), or symptoms (eg, hallucinations) that could affect the subject's ability to complete the study.
- Geriatric depression scale score of more than 6 or has suicidal ideation.
- Current clinically significant chronic illness that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study, including uncontrolled diabetes. Subjects with a history of diabetic ketoacidosis will also be excluded. Other cases of diabetes will be decided at the discretion of the study physicians. Subjects with diabetes controlled with exercise and diet may be screened and admission to study will depend on their screening safety laboratory assessments.
- History of clinically evident stroke or history of clinically significant carotid or vertebrobasilar stenosis or plaque and other risk factors for thromboembolic stroke (e.g atrial fibrillation, clinically significant low ventricular output, atrial septal defect).
- History of seizures.
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- Clinically significant infection within the last 30 days (eg, chronic persistent or acute infection [eg, upper respiratory infection, urinary tract infection]),prior to screening.
- Myocardial infarction within the last 2 years.
- Abnormal screening visit electrocardiogram (ECG), in the opinion of the investigator.
- Uncontrolled hypertension within the last 6 months prior to screening.
- History of cancer within the last 3 years, with the exception of nonmetastatic basal cell carcinoma and squamous cell carcinoma of the skin. (Note: cancer must be in remission with no signs of progression.)
- Use of experimental or other investigational medications/devices for treatment within 90 days prior to screening.
- Laboratory findings of fasting total cholesterol greater than or equal to 240 mg/dL
- Laboratory findings of fasting triglycerides greater than or equal to 200 mg/dL
- Laboratory findings of fasting glucose greater than or equal to 126 mg/dL
- Other clinically significant abnormality on physical, neurological, laboratory, vital signs, or ECG examination (eg, changes consistent with recent infarction, ischemia, clinically significant arrhythmias and clinically significant conduction defects) that could be detrimental to the subject or compromise the study.
- Does not have adequate venous access that would allow blood draws.
- Subject or study partner is related to study personnel.
- Subjects who have taken coconut oil as a supplement within the last 30 days.
- Subjects who have taken Axona™ within the last 30 days.
- Women who are pregnant. (Women who are of child bearing potential must take precautions to not become pregnant during the study.)
Trial locations and contacts
1 site in 1 country.
United States1 site
USF Health Byrd Alzheimer's Institute
Tampa, Florida, 33613
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, 6 Month Cross-Over Study to Evaluate the Efficacy of Coconut Oil (Fuel for Thought™) Treatment for Subjects With Mild to Moderate Alzheimer's Disease
This is a randomized, cross over study to determine the efficacy of coconut oil in subjects with mild to moderate Alzheimer's disease.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, cross over study to determine the efficacy of coconut oil (a proprietary blend of coconut and medium chain triglyceride oils, administered orally three times daily) to subjects with Alzheimer's disease who have been screened for ApoE 4 allele. The study medication formula is Cognate Nutritionals Fuel for Thought™.
Approximately 65 subjects will be treated with a coconut oil beverage (Fuel for Thought™) or placebo for three months, and then given a 3-5 day interim wash out period. After this, subjects will resume with three months treatment in opposite treatment arm. Total treatment period is 6 months.
- Conditions
- Alzheimer's Disease
- Being tested
- Coconut Oil Beverage, Placebo Beverage
- Keywords
- Mild to Moderate Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut Oil BeverageDrug
Also called Fuel for Thought (TM)
There are 2 treatment arms: Fuel for Thought™ and placebo, with a treatment allocation of 1:1. After 3 months of treatment in one group, subjects will have a 3-5 day wash-out period before receiving the alternate (opposite) treatment for 3 months.
Placebo BeverageOther
There are 2 treatment arms: Fuel for Thought™ and placebo, with a treatment allocation of 1:1. After 3 months of treatment in one group, subjects will have a 3-5 day wash-out period before receiving the alternate (opposite) treatment for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Coconut Oil Beverage | Experimental | The treatment will consist of a 1.25 oz serving size taken orally, two times daily by subjects. This treatment arm will last 3 months. Receives: Drug: Coconut Oil Beverage |
| Placebo Beverage | Placebo comparator | The treatment will consist of a 1.25 oz serving size taken orally, two times daily by subjects.This will similar in look and taste but not have the same ingredients of the actual coconut oil beverage. This treatment arm will last 3 months. Receives: Other: Placebo Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in cognitive testing (ADAS-cog, MMSE, Category/Letter Fluency)
Measured: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in cognitive testing (ADAS-cog, MMSE, Category/Letter Fluency)
Secondary outcomes (6)
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in Trails A & B cognitive testing
Measured: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in Trails A & B cognitive testing
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) on Geriatric Depression Scale
Measured: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) on Geriatric Depression Scale
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in behaviors measured by Neuropsychiatric Inventory
Measured: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in behaviors measured by Neuropsychiatric Inventory
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in functional ability measured by Activities of Daily Living (ADCS-ADLs)
Measured: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in functional ability measured by Activities of Daily Living (ADCS-ADLs)
Measure changes in Ketone & C-Reactive Protein assays from research blood samples throughout study during the 2 treatment periods from Baseline to Month 6 (change during a total 6 month period of time).
Measured: Measure changes in Ketone & C-Reactive Protein assays from research blood samples throughout study during the 2 treatment periods from Baseline to Month 6 (change during a total 6 month period of time).
Adverse events related to coconut oil usage during 6 months of treatment periods (change during a total 6 month period of time).
Measured: Adverse events related to coconut oil usage during 6 months of treatment periods (change during a total 6 month period of time).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completion1 Feb 2017
- Study completion1 Feb 2017
Why it stopped: Funding limitations and enrollment was too low.
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 South FloridaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda G Smith, MD, Principal investigator, USF Health Byrd Alzheimer's Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883648
- Sponsor's protocol ID
- Byrd AD-001
- Status last verified
- Jan 2017
- First submitted
- 11 Jun 2013
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, 6 Month Cross-Over Study to Evaluate the Efficacy of Coconut Oil (Fuel for Thought™) Treatment for Subjects With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01883648
- Acronym / sponsor ID
- Byrd AD-001
- Conditions
- Alzheimer's Disease
- Keywords
- Mild to Moderate Alzheimer's disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding limitations and enrollment was too low.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 21 Jun 2013 (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.
This is a randomized, cross over study to determine the efficacy of coconut oil in subjects with mild to moderate Alzheimer's disease.
Detailed description
This is a randomized, double-blind, placebo-controlled, cross over study to determine the efficacy of coconut oil (a proprietary blend of coconut and medium chain triglyceride oils, administered orally three times daily) to subjects with Alzheimer's disease who have been screened for ApoE 4 allele. The study medication formula is Cognate Nutritionals Fuel for Thought™.
Approximately 65 subjects will be treated with a coconut oil beverage (Fuel for Thought™) or placebo for three months, and then given a 3-5 day interim wash out period. After this, subjects will resume with three months treatment in opposite treatment arm. Total treatment period is 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coconut Oil Beverage | Experimental | Drug: Coconut Oil BeverageThe treatment will consist of a 1.25 oz serving size taken orally, two times daily by subjects. This treatment arm will last 3 months. |
| Placebo Beverage | Placebo comparator | Other: Placebo BeverageThe treatment will consist of a 1.25 oz serving size taken orally, two times daily by subjects.This will similar in look and taste but not have the same ingredients of the actual coconut oil beverage. This treatment arm will last 3 months. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women aged 55 to 90 years with a diagnosis of mild to moderate Alzheimer's disease
- Informed consent signed and dated by subject (or legally authorized representative).
- Subjects must have a study partner must also consent to participate in the study, who they spend at least 10 hours/week with during the study. The study partner must attend applicable clinic visits and provide information about the subject.
- Subject must have a screening Mini-Mental State Examination score of 16-26.
- Subjects must have a Rosen Modified Hachinski Ischemic score of ≤4.
Key exclusion criteria (21 listed)
- Has significant neurological or medical disease, other than AD, that may affect cognition, for example, history or evidence of hydrocephalus, or uncontrolled hypo- or hyperthyroidism.
- Current, clinically significant major psychiatric disorder (eg, major depressive disorder) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSMIV), or symptoms (eg, hallucinations) that could affect the subject's ability to complete the study.
- Geriatric depression scale score of more than 6 or has suicidal ideation.
- Current clinically significant chronic illness that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study, including uncontrolled diabetes. Subjects with a history of diabetic ketoacidosis will also be excluded. Other cases of diabetes will be decided at the discretion of the study physicians. Subjects with diabetes controlled with exercise and diet may be screened and admission to study will depend on their screening safety laboratory assessments.
- History of clinically evident stroke or history of clinically significant carotid or vertebrobasilar stenosis or plaque and other risk factors for thromboembolic stroke (e.g atrial fibrillation, clinically significant low ventricular output, atrial septal defect).
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 |
|---|---|---|
| Coconut Oil BeverageAlso: Fuel for Thought (TM)There are 2 treatment arms: Fuel for Thought™ and placebo, with a treatment allocation of 1:1. After 3 months of treatment in one group, subjects will have a 3-5 day wash-out period before receiving the alternate (opposite) treatment for 3 months. | Drug | Coconut Oil Beverage |
| Placebo BeverageThere are 2 treatment arms: Fuel for Thought™ and placebo, with a treatment allocation of 1:1. After 3 months of treatment in one group, subjects will have a 3-5 day wash-out period before receiving the alternate (opposite) treatment for 3 months. | Other | Placebo Beverage |
Primary outcome
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in cognitive testing (ADAS-cog, MMSE, Category/Letter Fluency)
Time frame: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in cognitive testing (ADAS-cog, MMSE, Category/Letter Fluency)
6 secondary outcomes
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in Trails A & B cognitive testing
Time frame: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in Trails A & B cognitive testing
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) on Geriatric Depression Scale
Time frame: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) on Geriatric Depression Scale
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in behaviors measured by Neuropsychiatric Inventory
Time frame: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in behaviors measured by Neuropsychiatric Inventory
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in functional ability measured by Activities of Daily Living (ADCS-ADLs)
Time frame: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in functional ability measured by Activities of Daily Living (ADCS-ADLs)
Measure changes in Ketone & C-Reactive Protein assays from research blood samples throughout study during the 2 treatment periods from Baseline to Month 6 (change during a total 6 month period of time).
Time frame: Measure changes in Ketone & C-Reactive Protein assays from research blood samples throughout study during the 2 treatment periods from Baseline to Month 6 (change during a total 6 month period of time).
Adverse events related to coconut oil usage during 6 months of treatment periods (change during a total 6 month period of time).
Time frame: Adverse events related to coconut oil usage during 6 months of treatment periods (change during a total 6 month period of time).
Results and safety
The study was stopped early (reason given: Funding limitations and enrollment was too low.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Amanda G Smith, MD principal investigator
USF Health Byrd Alzheimer's Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Coconut Oil Beverage in people with Alzheimer's Disease, run by University of South Florida at 1 site in United States.
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 11 inclusion and 21 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: stopped early, as of the sponsor's last update on 28 Apr 2017. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding limitations and enrollment was too low.). Results are not available in the source record.
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?
Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in cognitive testing (ADAS-cog, MMSE, Category/Letter Fluency) (time frame: Change from baseline to Month 3 of each treatment phase (a 3 month period of time) in cognitive testing (ADAS-cog, MMSE, Category/Letter Fluency)). 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 28 Apr 2017.