Alzheimer DiseasePhase 3ALTER-ADNCT05809908
Tricaprilin Phase 3 ALTER-AD (Alternative-Alzheimer Disease) Study
A Phase 3 study testing Tricaprilin in people with Alzheimer Disease, run by Cerecin.
Trial summary
The purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, global function, activities of daily living, resource utilisation, safety, and tolerability, in participants with mild to moderate AD dementia. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer 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
- 535 participants
- Where
- No sites listed yet
- Study dates
- Jul 2027to Feb 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mini Mental State Exam (MMSE) score between 14 to 24
- Meets diagnostic clinical criteria of probable Alzheimer's disease dementia according to the NIA-AA criteria
- Magnetic resonance imaging (MRI) scan less than 12 months before Baseline compatible with a diagnosis of probable AD
- Plasma biomarker result supporting a diagnosis of AD before Baseline (Aβ42/40 and/or pTau217)
- Confirmed APOE4 genotype result prior to Baseline
- Participants taking the following cholinesterase inhibitors: donepezil, galantamine, or rivastigmine; and/or sodium oligomannate (GV-971), and/or memantine, and/or GLP-1 antagonist and/or other agents which may impact cognition are eligible for enrolment: a) If the participant has been taking such medication(s)/products for 3 months or more at Screening Visit 1; b) If the current dosage regimen is within the approved dose range; c) The daily dose has remained unchanged for at least 6 weeks prior to screening; d) If the dose is not expected to change during study participation
Who cannot join
- Has any medical/neurological/psychiatric condition, other than AD, that could explain the participant's dementia or cognitive impairment, such as but not limited to e.g., structural abnormality, traumatic brain injury, stroke, epilepsy, Parkinson's disease, alcohol-related dementia, current major depressive episode
- The following GI conditions are exclusionary: a) 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. Participants with remote quiescent disease, at the Investigators discretion , are not excluded; b) Participants with current or a history of (within the last 5 years) any of the following conditions are excluded: clinically significant reflux disease (e.g., Barrett's oesophagus, stricture, ulcer, haemorrhage), or severe gastroesophageal reflux disease that, in the opinion of the Investigator, is not well-controlled by medication; c) 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; d) History of gastric food intolerance, whether it be allergy or chronic oversensitivity, or a history of stomach upset reaction to a variety of foods
- Current or previous treatment with any anti-amyloid or anti-Tau antibodies such as lecanemab and donanemab within 6 months prior to the day of screening
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-OLE-01-VA in Participants With Mild to Moderate Alzheimer's Disease Dementia
The purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, global function, activities of daily living, resource utilisation, safety, and tolerability, in participants with mild to moderate AD dementia.
This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre design in up to 535 participants.
- Conditions
- Alzheimer 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
Each dose of IMP will be administered orally 30 minutes after completing a full meal.
There is 1 g of tricaprilin per 2 ml of AC-OLE-01-VA.
Participants will titrate from 5 g twice a day to 20 g twice a day, up to 40 g total daily dose of tricaprilin; 80 ml total daily dose of AC-OLE-01-VA, over the course of 2-4 weeks.
PlaceboDrug
Each dose of IMP will be administered orally 30 minutes after completing a full meal.
Participants will titrate from 5 g twice a day to 20 g twice a day, up to 40 g total daily dose of placebo; 80 ml total daily dose of placebo, over the course of 2-4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Tricaprilin | Active comparator | Tricaprilin formulation twice daily for 26 weeks, liquid for oral administration Receives: Drug: Tricaprilin |
| Placebo | Placebo comparator | Placebo formulation, twice daily for 26 weeks, liquid for oral administration 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-Cog) total score
The ADAS-Cog is a cognitive scale that assesses memory, language, orientation, and praxis with a total score range of 0 (no impairment) to 70 (severe impairment).
Measured: 26 weeks
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
The ADCS-CGIC is a clinician-rated scale of cognition, function, and behavior. Scores range from 1 (marked improvement) to 7 (marked worsening).
Measured: 26 weeks
Secondary outcomes (2)
Change From Baseline in a composite score of Category Fluency Test (CFT), Controlled Oral Word Association Test (COWAT), and ADAS-Cog subtests Word Recall, Word Recognition and Orientation
The CFT is a cognitive test assessing a participant's semantic fluency, a measure of executive function. Participants are given 60 seconds to name as many examples of a category, with 1 point for each correct, unique response given.
The COWAT is a cognitive test assessing a participant's phonemic fluency, a measure of executive function. Participants are given 60 seconds (per word) to say as many words as possible beginning e.g., with the letters F, A and S (in English, equivalents will be used for other languages), with 1 point for each original and correct word.
The ADAS-Cog is a cognitive scale that assesses memory, language, orientation, and praxis with a total score range of 0 (no impairment) to 70 (severe impairment).
Measured: 26 weeks
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score
The ADCS-ADL is a 23-item semi-structured interview with a caregiver and assesses 6 basic activities of daily living and 7 instrumental activities of daily living with a total score of 0 to 78. Lower scores indicate greater severity.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study startJul 2027 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- 535 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cerecin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809908
- Sponsor's protocol ID
- AC-22-027
- Acronym
- ALTER-AD
- Status last verified
- Oct 2026
- First submitted
- 30 Mar 2023
- Last updated
- 30 Oct 2026
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, 26-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Daily Administration of Tricaprilin as AC-OLE-01-VA in Participants With Mild to Moderate Alzheimer's Disease Dementia
- ClinicalTrials.gov ID
- NCT05809908
- Acronym / sponsor ID
- ALTER-AD / AC-22-027
- Conditions
- Alzheimer Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 535 participants (estimated)
- Lead sponsor
- CerecinIndustry (pharma, biotech, devices)
- Study start
- Jul 2027 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 12 Apr 2023 (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.
The purpose of this study is to evaluate the effects of tricaprilin (20 g twice a day) on cognition, global function, activities of daily living, resource utilisation, safety, and tolerability, in participants with mild to moderate AD dementia.
This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre design in up to 535 participants.
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 |
|---|---|---|
| Tricaprilin | Active comparator | Drug: TricaprilinTricaprilin formulation twice daily for 26 weeks, liquid for oral administration |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo formulation, twice daily for 26 weeks, liquid for oral administration |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mini Mental State Exam (MMSE) score between 14 to 24
- Meets diagnostic clinical criteria of probable Alzheimer's disease dementia according to the NIA-AA criteria
- Magnetic resonance imaging (MRI) scan less than 12 months before Baseline compatible with a diagnosis of probable AD
- Plasma biomarker result supporting a diagnosis of AD before Baseline (Aβ42/40 and/or pTau217)
- Confirmed APOE4 genotype result prior to Baseline
Key exclusion criteria (3 listed)
- Has any medical/neurological/psychiatric condition, other than AD, that could explain the participant's dementia or cognitive impairment, such as but not limited to e.g., structural abnormality, traumatic brain injury, stroke, epilepsy, Parkinson's disease, alcohol-related dementia, current major depressive episode
- The following GI conditions are exclusionary: a) 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. Participants with remote quiescent disease, at the Investigators discretion , are not excluded; b) Participants with current or a history of (within the last 5 years) any of the following conditions are excluded: clinically significant reflux disease (e.g., Barrett's oesophagus, stricture, ulcer, haemorrhage), or severe gastroesophageal reflux disease that, in the opinion of the Investigator, is not well-controlled by medication; c) 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; d) History of gastric food intolerance, whether it be allergy or chronic oversensitivity, or a history of stomach upset reaction to a variety of foods
- Current or previous treatment with any anti-amyloid or anti-Tau antibodies such as lecanemab and donanemab within 6 months prior to the day of screening
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 |
|---|---|---|
| TricaprilinEach dose of IMP will be administered orally 30 minutes after completing a full meal. There is 1 g of tricaprilin per 2 ml of AC-OLE-01-VA. Participants will titrate from 5 g twice a day to 20 g twice a day, up to 40 g total daily dose of tricaprilin; 80 ml total daily dose of AC-OLE-01-VA, over the course of 2-4 weeks. | Drug | Tricaprilin |
| PlaceboEach dose of IMP will be administered orally 30 minutes after completing a full meal. Participants will titrate from 5 g twice a day to 20 g twice a day, up to 40 g total daily dose of placebo; 80 ml total daily dose of placebo, over the course of 2-4 weeks. | Drug | Placebo |
Primary outcome
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) total score
Time frame: 26 weeks
The ADAS-Cog is a cognitive scale that assesses memory, language, orientation, and praxis with a total score range of 0 (no impairment) to 70 (severe impairment).
Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
Time frame: 26 weeks
The ADCS-CGIC is a clinician-rated scale of cognition, function, and behavior. Scores range from 1 (marked improvement) to 7 (marked worsening).
2 secondary outcomes
Change From Baseline in a composite score of Category Fluency Test (CFT), Controlled Oral Word Association Test (COWAT), and ADAS-Cog subtests Word Recall, Word Recognition and Orientation
Time frame: 26 weeks
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tricaprilin in people with Alzheimer 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 6 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (6568132999, clinical@cerecin.com), or a site near the patient. 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-Cog) total score (time frame: 26 weeks). 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?
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 30 Oct 2026.