Alzheimer's DiseasePhase 2/3ALERTNCT01211782
AC-1204 Long-term Efficacy Response Trial (ALERT Protocol)
A Phase 2/3 study testing caprylic triglyceride and long-chain triglyceride in people with Alzheimer's Disease, run by Cerecin at 1 site in United States.
Trial summary
The study will evaluate the safety \& efficacy of AC-1204, a ketogenic compound, administered orally on a daily basis for 6 months. Following the 6 month double-blind phase of the study, subjects may enroll in an optional 6 month open-label extension phase. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- caprylic triglyceride and long-chain triglyceride
- 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
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males/females between age of 55 -85 years
- MMSE scores between 16-26
- Probable mild to moderate AD
Who cannot join
- Presence of other CNS disorders as alternative causes of dementia
- Type 1 or Type 2 diabetes
- Significant renal/hepatic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2-3, 6-12 Month, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Daily Administration of AC-1204 in Subjects With Mild to Moderate Alzheimer's Disease Who Are APOE4(-)
The study will evaluate the safety \& efficacy of AC-1204, a ketogenic compound, administered orally on a daily basis for 6 months. Following the 6 month double-blind phase of the study, subjects may enroll in an optional 6 month open-label extension phase. Efficacy will be evaluated by standard tests of memory and cognition, along with other measurements of activities of daily living and quality of life. Safety will be assessed by frequency of adverse events and changes in laboratory test results. Subjects will be stratified and outcomes will be separately analyzed based on apolipoprotein E4 genotype (APOE4).
Read the detailed description
Two primary outcome measures will be assessed in APOE4(-) patients:
- differences from baseline between AC-1204 and placebo groups' ADAS-cog scores at 6 months
- differences from baseline between AC-1204 and placebo groups' CIBIC+ scores at 6 months Secondary endpoints will include differences between AC-1204 \& placebo groups' scores for these same instruments at 3 months.
- Conditions
- Alzheimer's Disease
- Being tested
- caprylic triglyceride, long-chain triglyceride
- Keywords
- Alzheimer's disease, AD, AC-1204, ketogenic, ketosis
- Medical subject headings
- Alzheimer Disease, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caprylic triglycerideDrug
Also called AC-1204
oral, 20 gm, daily x 6 months
long-chain triglycerideDrug
Also called sunflower oil + maltodextrin
oral, 14 gm, daily x 6 months
| Study group | Role | What they receive |
|---|---|---|
| AC-1204 | Experimental | Not described Receives: Drug: caprylic triglyceride |
| Placebo | Placebo comparator | Not described Receives: Drug: long-chain triglyceride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog)
change from baseline in ADAS-cog scores at 6 months in APOE4(-) patients
Measured: 6 months
Secondary outcomes (1)
Clinicians Interview Based Impression of Change with Caregiver Input (CIBIC+)
change from baseline in CIBIC+ scores at 6 months in APOE4(-) patients
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
Why it stopped: Study never started. Study was redesgined.
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 2/3
- 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
- Investigators
- Mildred Farmer, MD, Principal investigator, Meridien Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211782
- Sponsor's protocol ID
- AC-10-006
- Acronym
- ALERT
- Status last verified
- Dec 2012
- First submitted
- 24 Sep 2010
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2-3, 6-12 Month, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Daily Administration of AC-1204 in Subjects With Mild to Moderate Alzheimer's Disease Who Are APOE4(-)
- ClinicalTrials.gov ID
- NCT01211782
- Acronym / sponsor ID
- ALERT / AC-10-006
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, AD, AC-1204, ketogenic, ketosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started. Study was redesgined.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CerecinIndustry (pharma, biotech, devices)
- First posted
- 30 Sep 2010 (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 study will evaluate the safety \& efficacy of AC-1204, a ketogenic compound, administered orally on a daily basis for 6 months. Following the 6 month double-blind phase of the study, subjects may enroll in an optional 6 month open-label extension phase. Efficacy will be evaluated by standard tests of memory and cognition, along with other measurements of activities of daily living and quality of life. Safety will be assessed by frequency of adverse events and changes in laboratory test results. Subjects will be stratified and outcomes will be separately analyzed based on apolipoprotein E4 genotype (APOE4).
Detailed description
Two primary outcome measures will be assessed in APOE4(-) patients:
- differences from baseline between AC-1204 and placebo groups' ADAS-cog scores at 6 months
- differences from baseline between AC-1204 and placebo groups' CIBIC+ scores at 6 months Secondary endpoints will include differences between AC-1204 \& placebo groups' scores for these same instruments at 3 months.
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-1204 | Experimental | Drug: caprylic triglyceride |
| Placebo | Placebo comparator | Drug: long-chain triglyceride |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males/females between age of 55 -85 years
- MMSE scores between 16-26
- Probable mild to moderate AD
Key exclusion criteria (3 listed)
- Presence of other CNS disorders as alternative causes of dementia
- Type 1 or Type 2 diabetes
- Significant renal/hepatic disease
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 |
|---|---|---|
| caprylic triglycerideAlso: AC-1204oral, 20 gm, daily x 6 months | Drug | AC-1204 |
| long-chain triglycerideAlso: sunflower oil + maltodextrinoral, 14 gm, daily x 6 months | Drug | Placebo |
Primary outcome
Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog)
Time frame: 6 months
change from baseline in ADAS-cog scores at 6 months in APOE4(-) patients
1 secondary outcome
Clinicians Interview Based Impression of Change with Caregiver Input (CIBIC+)
Time frame: 6 months
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 4 Dec 2012.
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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.
Mildred Farmer, MD principal investigator
Meridien Research
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 caprylic triglyceride and long-chain triglyceride in people with Alzheimer's Disease, run by Cerecin 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 3 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: withdrawn, as of the sponsor's last update on 4 Dec 2012. 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 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?
Alzheimer's disease assessment scale - cognitive subscale (ADAS-cog) (time frame: 6 months). 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 4 Dec 2012.