Alzheimer DiseasePhase 4ADNCT01122329
A Positron Emission Tomography (PET) Study Evaluating Brain Metabolism of a Medical Food in Alzheimer's Disease
A Phase 4 study testing caprylidene in people with Alzheimer Disease, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
This study will examine the brain metabolic effects of AC-1202 (Axona®), a medical food for Alzheimer's disease. Subjects who meet entry criteria will undergo H215O positron emission tomography prior to and 90 minutes after consumption of Axona® at baseline and then again after 45 days of treatment. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- caprylidene
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Jan 2015
- Phase
- Phase 4
- 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
- Diagnosis of probable AD (NINDS-ADRDA criteria(32))
- Age 50 - 90 (inclusive)
- MMSE range: 10 to 28
- Participants may be taking medications for AD, provided that the dose of these medications has been stable for > 90 days
- Proficiency in English to be able to perform cognitive tests
- A caregiver must be available to monitor and administer treatment and to accompany the subject to every clinical visit.
Who cannot join
- Inability for any reason to undergo PET/CT scans
- Previous treatment with AC-1202
- Allergic to milk or soy
- Presence of neurodegenerative disease other than AD
- History of stroke or other injury that could result in cognitive impairment
- Psychiatric disorder
Show all 10Show fewer
- Diabetes mellitus
- Recent (<90 days) changes to medications prescribed for cognitive reasons or with the potential to impact cognition
- Irritable bowel syndrome (IBS) or other gastrointestinal conditions that could interfere with treatment compliance
- Any factor deemed by the investigator to be likely to interfere with study conduction
Trial locations and contacts
2 sites in 1 country.
United States2 sites
200 Medical Plaza, UCLA Medical Center
Los Angeles, California, 90095
Center for Neurotherapeutics at UCLA
Los Angeles, California, 90095
About this study
Official title: A Single-site Positron Emission Tomography (PET) Study of the Cerebral Metabolic Effects of AC-1202 (Axona®) Treatment in Mild-to-Moderate Alzheimer's Disease (AD)
This study will examine the brain metabolic effects of AC-1202 (Axona®), a medical food for Alzheimer's disease. Subjects who meet entry criteria will undergo H215O positron emission tomography prior to and 90 minutes after consumption of Axona® at baseline and then again after 45 days of treatment. Cognitive testing will also be conducted at baseline and day 45.
- Conditions
- Alzheimer Disease
- Being tested
- caprylidene, Placebo
- Keywords
- dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
caprylideneDietary supplement
Also called Axona®, AC-1202
Axona® is dosed as a 40g packet mixed into 8 oz of liquid (Ensure) for 45 days
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| inactive food packet | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| Axona® | Active comparator | Not described Receives: Dietary Supplement: caprylidene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional cerebral blood flow (rCBF)
Measured: At baseline
Regional cerebral blood flow (rCBF)
Measured: 90 minutes after initation of treatment with Axona®
Regional cerebral blood flow (rCBF)
Measured: 45 days after initation of treatment with Axona®
Secondary outcomes (6)
Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition
Measured: At baseline
To examine the effect of AC-1202 on cognition
Measured: At baseline
Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition
Measured: At 90 minutes after initiation of treatment with Axona®
Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition
Measured: 45 days after initiation of treatment with Axona®
To examine the effect of AC-1202 on cognition
Measured: At 90 minutes after initiation of treatment with Axona®
To examine the effect of AC-1202 on cognition
Measured: 45 days after initiation of treatment with Axona®
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startOct 2010
- Primary completionJan 2015
- Study completionJan 2015
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.
- More trials run by University of California, Los AngelesThe 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- John Douglas French Foundation
- Responsible party
- Principal investigator, Joshua Grill, PhD, University of California, Los Angeles
- Investigators
- Joshua Grill, PhD, Principal investigator, Mary S. Easton Center for Alzheimer's Disease Research at UCLAJohn Ringman, MD, Study chair, Mary S. Easton Center for Alzheimer's Disease Research at UCLAMaryam Beigi, MD, Study chair, Mary S. Easton Center for Alzheimer's Disease Research at UCLAEllen Woo, PhD, Study chair, Mary S. Easton Center for Alzheimer's Disease Research at UCLADan Silverman, MD, PhD, Study chair, UCLA Department of Molecular and Medical PharmacologyCathy Lee, PhD, Study chair, Mary S. Easton Center for Alzheimer's Disease Research at UCLAJeffrey Cummings, MD, Study chair, Mary S. Easton Center for Alzheimer's Disease Research at UCLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122329
- Sponsor's protocol ID
- GG-AC-1202
- Acronym
- AD
- Status last verified
- Mar 2015
- First submitted
- 11 May 2010
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-site Positron Emission Tomography (PET) Study of the Cerebral Metabolic Effects of AC-1202 (Axona®) Treatment in Mild-to-Moderate Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT01122329
- Acronym / sponsor ID
- AD / GG-AC-1202
- Conditions
- Alzheimer Disease
- Keywords
- dementia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- John Douglas French Foundation
- Study start
- Oct 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 May 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.
This study will examine the brain metabolic effects of AC-1202 (Axona®), a medical food for Alzheimer's disease. Subjects who meet entry criteria will undergo H215O positron emission tomography prior to and 90 minutes after consumption of Axona® at baseline and then again after 45 days of treatment. Cognitive testing will also be conducted at baseline and day 45.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inactive food packet | Placebo comparator | Dietary Supplement: Placebo |
| Axona® | Active comparator | Dietary Supplement: caprylidene |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of probable AD (NINDS-ADRDA criteria(32))
- Age 50 - 90 (inclusive)
- MMSE range: 10 to 28
- Participants may be taking medications for AD, provided that the dose of these medications has been stable for > 90 days
- Proficiency in English to be able to perform cognitive tests
Key exclusion criteria (10 listed)
- Inability for any reason to undergo PET/CT scans
- Previous treatment with AC-1202
- Allergic to milk or soy
- Presence of neurodegenerative disease other than AD
- History of stroke or other injury that could result in cognitive impairment
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 |
|---|---|---|
| caprylideneAlso: Axona®, AC-1202Axona® is dosed as a 40g packet mixed into 8 oz of liquid (Ensure) for 45 days | Dietary supplement | Axona® |
| Placebo | Dietary supplement | inactive food packet |
Primary outcome
Regional cerebral blood flow (rCBF)
Time frame: At baseline
Regional cerebral blood flow (rCBF)
Time frame: 90 minutes after initation of treatment with Axona®
Regional cerebral blood flow (rCBF)
Time frame: 45 days after initation of treatment with Axona®
6 secondary outcomes
Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition
Time frame: At baseline
To examine the effect of AC-1202 on cognition
Time frame: At baseline
Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition
Time frame: At 90 minutes after initiation of treatment with Axona®
Examine differences between ApoE ε4 carriers and noncarriers in changes on rCBF and cognition
Time frame: 45 days after initiation of treatment with Axona®
To examine the effect of AC-1202 on cognition
Time frame: At 90 minutes after initiation of treatment with Axona®
To examine the effect of AC-1202 on cognition
Time frame: 45 days after initiation of treatment with Axona®
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 Mar 2015.
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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.
Joshua Grill, PhD principal investigator
Mary S. Easton Center for Alzheimer's Disease Research at UCLA
John Ringman, MD study chair
Mary S. Easton Center for Alzheimer's Disease Research at UCLA
Maryam Beigi, MD study chair
Mary S. Easton Center for Alzheimer's Disease Research at UCLA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing caprylidene in people with Alzheimer Disease, run by University of California, Los Angeles at 2 sites 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 6 inclusion and 10 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 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Regional cerebral blood flow (rCBF) (time frame: At baseline). The study lists 3 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 Mar 2015.