Alzheimer's DiseasePhase 3NCT04187547
A Phase III Multi Regional Clinical Trial (MRCT) of Tricaprilin in Mild to Moderately Severe Probable Alzheimer's Disease With Optional Open Label Extension
A Phase 3 study testing Tricaprilin in people with Alzheimer's Disease, run by Cerecin.
Trial summary
This is Phase 3 study, multi-centre, double-blind, placebo controlled, parallel group to evaluate the effects of AC-SD-03 on the efficacy and safety among participants with mild to moderate Alzheimer's Disease. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Tricaprilin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2022to 28 Feb 2024
- Phase
- Phase 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects between the ages of 50 and 85 (inclusive) at the time of Screening Visit 1. Subjects 86 to 90 years of age (inclusive) can be enrolled, provided that the Medical Monitor reviews the subject's medical condition during the screening process and approves enrolment.
- Dementia of mild to moderate severity, as classified by MMSE score between 14 to 26, inclusive, at Screening Visit 1.
- Meets diagnostic clinical criteria of probable Alzheimer's dementia according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) [25].
- Magnetic resonance imaging prior to Visit 3 (Baseline) compatible with a diagnosis of probable AD.
- Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) brain scan showing a pattern typical for AD according to central PET reader (with areas of glucose hypometabolism in posterior cingulate, temporal, parietal, and/or prefrontal cortices, as per criteria in imaging manual).
- Confirmed APOE negative genotype result obtained by the central laboratory prior to Screening Visit 2 or documented prior to screening.
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- Subjects taking the following cholinesterase inhibitors (ChEI): donepezil, galantamine, or rivastigmine; and/or GV-971, and/or memantine and/or other agents which may impact cognition (e.g., Souvenaid®, NeuroAidTM, Cerefolin®, Gingko biloba, etc) are eligible for enrolment:
- If the subject has been taking such medication(s)/products for 3 months or more at Screening Visit 1.
- If the current dosage regimen is within the approved dose range.
- The daily dose has remained unchanged for at least 6 weeks prior to screening.
- If the dose is not expected to change during trial participation.
- Tacrine use is not allowed.
- In the opinion of the Investigator, the subject's medical condition, except for dementia, has been stable for at least 3 consecutive months prior to Screening Visit 1.
- Subjects do not have active suicidal thoughts (answers 'yes' to questions 4 or 5, on the Columbia-Suicide Severity Rating Scale [C-SSRS]) within 6 months preceding Screening Visit 2 or Visit 3 (Baseline). Additionally, subjects have no active history of suicide attempt in the previous 2 years or more than 1 lifetime suicide attempt, nor are they at serious suicidal risk, in the opinion of the Investigator.
- The subject is able to comply with protocol testing and procedures for the entire length of the trial.
- Has a permanent caregiver (subject's caregiver is not expected to change during the trial) who is willing to attend all visits, oversee the subject's compliance with protocol-specified procedures and IP administration, and report on subject's status. Caregiver must have, in the opinion of the Investigator, enough contact with the subject to be able to perform the duties described above.
- The subject and caregiver are, in the Investigator's judgement, proficient in the language in which the trial assessments will be completed, and have hearing, vision and physical abilities adequate to perform assessments (corrective aids allowed).
- Subject and caregiver must provide full written informed consent prior to the performance of any protocol-specified procedure; or if subject is unable to provide informed consent due to cognitive status, provision of informed consent by cognitively intact legally acceptable representative (where this is in accordance with local laws, regulations and ethics committee policy).
- Subject is able to ingest oral medication.
- Subject is able to tolerate a 5 g dose of tricaprilin (formulated as 12.5 g of AC-SD-03) as per sentinel dose challenge at Visit 3 (Baseline).
Who cannot join
- Current use or use within 3 months of Visit 3 (Baseline), of Axona® or other MCT-containing products. Use of coconut oil up to 15 mL (1 tablespoon) per day is allowed. Use of MCT-containing products is not allowed at any time during trial participation.
- Use of any other investigational agent within 60 days prior to Screening Visit 1.
- Has a known allergy or hypersensitivity to triglycerides.
- In the opinion of the Investigator, has presence or history of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments, or put the subject at risk.
- Has any medical or neurological condition, other than AD, that could explain the subject's dementia (e.g., structural abnormality, traumatic brain injury, stroke, epilepsy, Parkinson's disease, alcohol-related dementia, etc.)
- Has a modified Hachinski Ischemia score greater than (>) 4 at Screening Visit 2.
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- Has a history or clinical laboratory evidence of cerebrovascular disease (stroke, transient ischemic attack, haemorrhage), or diagnosis of possible, probable, or definite vascular dementia at Screening Visit 1 in accordance with National Institute of Neurological Disorders and Stroke criteria.
- Brain MRI performed at Screening (prior to Visit 3) (per centrally read MRI) that shows evidence of any of the following:
- Acute, sub-acute or chronic haemorrhage.
- Cortical infarct (defined as > 1.5 cm in diameter).
- > 1 lacunar infarct (defined as < 1.5 cm in diameter).
- Superficial siderosis.
- History of diffuse white matter disease as defined by a score of 3 on the age-related white matter changes scale [26].
- Any finding that, in the opinion of the Investigator, might be a contributing cause of subject's dementia, might pose a risk to the subject, or might prevent a satisfactory MRI assessment for safety monitoring.
- Has a history or clinical laboratory evidence of moderate congestive heart failure defined by the New York Heart Association Criteria (Class I to IV).
- Clinically significant ECG abnormalities at Screening Visit 2, for example:
- Evidence of atrial fibrillation on ECG or history of atrial fibrillation that is not currently controlled
- QTcF at > 450 ms in males or > 470 ms in females, or low or flat T waves making measurement of QT interval unreliable
- Has a history of new ischemic or congestive cardiovascular event within the 3 months prior to Visit 3 (Baseline).
- Has a history of or current major psychiatric illness such as schizophrenia or bipolar affective disorder.
- Has a clinician-administered Patient Health Questionnaire (PHQ)-9 score of ≥ 10 or in the Investigator's opinion, depression of a severity that would impact cognitive assessments.
- Subjects with insulin dependent diabetes.
- Subjects with uncontrolled hypertension defined as:
- average of 3 systolic blood pressure [SBP]/diastolic blood pressure [DBP] readings > 165/100 mmHg at Screening Visit 2 (blood pressure measurements exceeding these limits may be repeated as warranted by the Investigator, but values must be within the specified limits for the subject to be eligible for the study),
- or persistent SBP/DBP readings > 180/100 mmHg 3 months prior to Baseline (Visit 3, Day 1) that in the opinion of the Investigator are indicative of chronic uncontrolled hypertension.
- Subjects with orthostatic hypotension, defined as a drop of >20 mmHg systolic blood pressure upon standing upright from a seated position within 3 minutes, at Screening Visit 2; testing for orthostatic hypotension may be repeated at Investigator's discretion if there is reason to believe the condition is temporary after addressing the temporary cause.
- At Screening Visit 2, clinically significant:
- anaemia (haemoglobin < 11 g/dL for males or < 10 g/dL for females)
- renal disease or insufficiency, including but not limited to a creatinine value of > 1.9 mg/dL (> 170 μmol/L)
- hypothyroidism
- At Screening Visit 2, laboratory test values (potential to repeat at Investigators discretion):
- ALT, AST, total bilirubin, or alkaline phosphatase > 2.5 times the ULN laboratory range, or history of severe hepatobiliary disease (e.g., hepatitis B or C, or cirrhosis [Childs-Pugh Classes B/C] without enzyme elevation)
- Fasting triglycerides > 2.5 times the ULN
- Cholesterol > 240 mg/dL
- Clinically significant Vitamin B12 deficiency within 12 months prior to Visit 1; however, subjects on stable replacement therapy for a minimum of 1 month immediately prior to Visit 1 may be included.
- The following GI conditions are exclusionary as described below:
- Inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), GI bleed (upper or lower), or peptic ulcer disease; any of these conditions are exclusionary, if active in the past 5 years. Subjects with remote quiescent disease, at Investigators discretion (and CER Committee) are not excluded.
- Subjects with current or a history of (within the last 5 years) any of the following conditions are excluded: complicated reflux disease (e.g., Barrett's oesophagus, stricture, ulcer, haemorrhage), or severe GERD that, in the opinion of the Investigator, is not well-controlled by medication.
- Irritable bowel syndrome, diverticular disease (e.g., diverticulosis, or diverticulitis), or chronic gastritis; any of these conditions are exclusionary if there has been an acute event within 1 year prior to Screening Visit 1.
- Has donated ≥ 2 units of blood within the 1 month prior to Screening Visit 1.
- Has a history of alcohol or drug abuse within the 6 months prior to Visit 1 or has tested positive upon urine drug screen at Screening Visit 2.
- Subject or caregiver is an immediate family member or employee of the clinical site, Sponsor, or of the Sponsor's agents.
- Has any current or history of neoplasm or malignancy, other than excised or treated basal cell carcinoma. The following exceptions may be made after discussion with the Medical Monitor:
- Subjects with cancers in remission more than 5 years prior to Screening.
- Subjects with a history of excised or treated squamous carcinoma of the skin.
- Subjects with prostate cancer in situ.
- Subject has a scheduled (or is expected to have scheduled) hospitalisation and/or surgery during the trial
About this study
Official title: A Phase III, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Trial to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-SD-03 in Subjects With Mild to Moderately Severe Probable Alzheimer's Disease and Who Are Noncarriers of the APOE4 Allele
This is Phase 3 study, multi-centre, double-blind, placebo controlled, parallel group to evaluate the effects of AC-SD-03 on the efficacy and safety among participants with mild to moderate Alzheimer's Disease.
- Conditions
- Alzheimer's Disease
- Being tested
- Tricaprilin, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TricaprilinDrug
Also called AC-SD-03
Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.
Each dosing unit of AC-SD-03 contains 20 g of the active ingredients (tricaprilin)
PlaceboDrug
Also called AC-SD-03P
Matching placebo to AC-SD-03 will be mixed with 240 mL water and shaken until fully dispersed.
| Study group | Role | What they receive |
|---|---|---|
| AC-SD-03 | Active comparator | Tricaprilin SD formulation, twice daily. Administered orally Receives: Drug: Tricaprilin |
| AC-SD-03P | Placebo comparator | Placebo formulation, twice daily. Administered orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11). Total Score up to 20-week Treatment
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog 11) is an 11- item cognitive subscale that objectively measures memory, language, orientation, and praxis with a total score range of 0 (no impairment) to 70 (severe impairment).
Measured: 20 weeks
Secondary outcomes (5)
Number of subjects with treatment related adverse events
TEAE incidence rate per treatment group
Measured: 20 weeks
Clinical Global Impression of Change
Clinician's global impression rated with Alzheimer's Disease cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
Measured: 20 weeks
Change From Baseline in Dependence Scale.Total Score up to 20-week Treatment
The Dependence Scale is a 13-item scale with a total score from 0 to 15, where higher scores indicate more dependence.
Measured: 20 weeks
Change From Baseline in RUD-Lite
The RUD-lite is an interview designed to assess resource utilisation required for subjects with dementia and their caregivers. Information gathered on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization).
Measured: 20 weeks
Change From Baseline in Disability Assessment for Dementia
The Disability Assessment for Dementia (DAD) is an interview designed to measure of functional ability in dementia.
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start30 Jun 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Why it stopped: Study replaced with a new study
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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerecin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187547
- Sponsor's protocol ID
- AC-19-020
- Status last verified
- Apr 2023
- First submitted
- 29 Nov 2019
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Trial to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-SD-03 in Subjects With Mild to Moderately Severe Probable Alzheimer's Disease and Who Are Noncarriers of the APOE4 Allele
- ClinicalTrials.gov ID
- NCT04187547
- Acronym / sponsor ID
- AC-19-020
- Conditions
- Alzheimer's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study replaced with a new study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CerecinIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 5 Dec 2019 (actual)
- 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 Phase 3 study, multi-centre, double-blind, placebo controlled, parallel group to evaluate the effects of AC-SD-03 on the efficacy and safety among participants with mild to moderate Alzheimer's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC-SD-03 | Active comparator | Drug: TricaprilinTricaprilin SD formulation, twice daily. Administered orally |
| AC-SD-03P | Placebo comparator | Drug: PlaceboPlacebo formulation, twice daily. Administered orally |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subjects between the ages of 50 and 85 (inclusive) at the time of Screening Visit 1. Subjects 86 to 90 years of age (inclusive) can be enrolled, provided that the Medical Monitor reviews the subject's medical condition during the screening process and approves enrolment.
- Dementia of mild to moderate severity, as classified by MMSE score between 14 to 26, inclusive, at Screening Visit 1.
- Meets diagnostic clinical criteria of probable Alzheimer's dementia according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) [25].
- Magnetic resonance imaging prior to Visit 3 (Baseline) compatible with a diagnosis of probable AD.
- Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) brain scan showing a pattern typical for AD according to central PET reader (with areas of glucose hypometabolism in posterior cingulate, temporal, parietal, and/or prefrontal cortices, as per criteria in imaging manual).
Key exclusion criteria (47 listed)
- Current use or use within 3 months of Visit 3 (Baseline), of Axona® or other MCT-containing products. Use of coconut oil up to 15 mL (1 tablespoon) per day is allowed. Use of MCT-containing products is not allowed at any time during trial participation.
- Use of any other investigational agent within 60 days prior to Screening Visit 1.
- Has a known allergy or hypersensitivity to triglycerides.
- In the opinion of the Investigator, has presence or history of an advanced, severe, progressive, or unstable disease of any type that could interfere with efficacy and safety assessments, or put the subject at risk.
- Has any medical or neurological condition, other than AD, that could explain the subject's dementia (e.g., structural abnormality, traumatic brain injury, stroke, epilepsy, Parkinson's disease, alcohol-related dementia, etc.)
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 |
|---|---|---|
| TricaprilinAlso: AC-SD-03Powder formulation will be mixed with 240 mL water and shaken until fully dispersed. Each dosing unit of AC-SD-03 contains 20 g of the active ingredients (tricaprilin) | Drug | AC-SD-03 |
| PlaceboAlso: AC-SD-03PMatching placebo to AC-SD-03 will be mixed with 240 mL water and shaken until fully dispersed. | Drug | AC-SD-03P |
Primary outcome
Change From Baseline in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11). Total Score up to 20-week Treatment
Time frame: 20 weeks
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog 11) is an 11- item cognitive subscale that objectively measures memory, language, orientation, and praxis with a total score range of 0 (no impairment) to 70 (severe impairment).
5 secondary outcomes
Number of subjects with treatment related adverse events
Time frame: 20 weeks
Clinical Global Impression of Change
Time frame: 20 weeks
Change From Baseline in Dependence Scale.Total Score up to 20-week Treatment
Time frame: 20 weeks
Change From Baseline in RUD-Lite
Time frame: 20 weeks
Change From Baseline in Disability Assessment for Dementia
Time frame: 20 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tricaprilin in people with Alzheimer's Disease, run by Cerecin.
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 20 inclusion and 47 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: withdrawn, as of the sponsor's last update on 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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 withdrawn before enrolling participants, so there are no results.
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 in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog11). Total Score up to 20-week Treatment (time frame: 20 weeks). 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 14 Apr 2023.