Age-Associated Memory ImpairmentPhase 2NCT00355550
Tricaprilin In Age-Associated Memory Impairment
A Phase 2 study testing Tricaprilin in people with Age-Associated Memory Impairment, run by Cerecin at 6 sites in United States.
Trial summary
The purpose of this study is to determine whether tricaprilin, a compound that increases energy availability in the brain, improves memory in older adults with "normal" loss of memory abilities since early adult life. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Age-Associated Memory Impairment
- 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
- 156 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2006to Jun 2007
- Phase
- Phase 2
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Complaints that memory has declined since young adult life
- Scores on standardized tests that are at least one standard deviation below the mean score of young adults
Who cannot join
- Dementia, including Alzheimer's disease and Mild Cognitive Impairment (MCI)
- Drugs that impair cognition
- Psychiatric conditions that may impair cognition (e.g.,depression etc.)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Meridien Research
Brooksville, Florida, 34613
University Clinical Research-DeLand
DeLand, Florida, 32720
Anchor Research Center
Naples, Florida, 34102
Renstar Medical Research
Ocala, Florida, 34471
University Clinical Research Center
Pembroke Pines, Florida, 33024
Meridien Research
St. Petersburg, Florida, 33709
About this study
Official title: A Double-Blind, Placebo-Controlled Study of Tricaprilin (AC-1202) Administered For Ninety Days In Subjects With Age-Associated Memory Impairment
The purpose of this study is to determine whether tricaprilin, a compound that increases energy availability in the brain, improves memory in older adults with "normal" loss of memory abilities since early adult life.
Read the detailed description
One physiological hallmark of aging in mammals is a decreased uptake and metabolism of glucose within the brain. The impaired glucose metabolism in the brain may contribute or exacerbate the cognitive deficits observed during normal aging. Facilitation of memory in elderly individuals occurs when glucose levels are elevated by the administration of carbohydrate. However, such a treatment poses challenges since elevated blood glucose levels are difficult to maintain and must be within a relatively narrow window, as excessive hyperglycemia is associated with cognitive impairments. The purpose of this study is to explore whether increasing levels of other substrates for the brain improves cognitive functioning in normal aged individuals with memory disorders.
Study participants will be 120 men and women aged 50-85 who have been diagnosed as having Age-Associated Memory Impairment (AAMI). During the double-blind period of the protocol, 60 participants will receive tricaprilin and 60 participants will receive a matching placebo. Tricaprilin or the matching placebo will be administered once a day for ninety days by mixing powder in 8 ounces of a liquid. Each participant will be seen six (6) times: at Screening; Baseline; treatment days Days 30, 60, 90; and 14 days after the conclusion of treatment (Day 104).
- Conditions
- Age-Associated Memory Impairment
- Being tested
- Tricaprilin, Placebo
- Keywords
- Mild Cognitive Impairment, Cognition disorders, nutritional supplement, dietary supplement
- Medical subject headings
- Cognitive Dysfunction, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TricaprilinDrug
Also called AC-1202
Powder formulation will be mixed in a liquid (approximately 8 oz).
PlaceboOther
Also called Matching placebo to AC-1202
Powder formulation will be mixed in a liquid (approximately 8 oz).
| Study group | Role | What they receive |
|---|---|---|
| AC-1202 | Active comparator | Tricaprilin formulation, once daily. Administered orally Receives: Drug: Tricaprilin |
| Matching Placebo to AC-1202 | Placebo comparator | Placebo formulation, once daily. Administered orally Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test)
Measured: 90 days
Number of subjects with treatment related adverse events
AE incidence rate per treatment group
Measured: 90 days
Secondary outcomes (1)
Self-reported memory improvement
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Associated Memory ImpairmentStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerecin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Henderson, PhD, Study chair, CerecinThomas H. Crook III, PhD, Principal investigator, Psychologix, Inc.Thomas Hochadel, Pharm.D., Study director, Advanced Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355550
- Sponsor's protocol ID
- KET-06-003
- Status last verified
- Sep 2020
- First submitted
- 20 Jul 2006
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Reger MA, Henderson ST, Hale C, Cholerton B, Baker LD, Watson GS, Hyde K, Chapman D, Craft S. Effects of beta-hydroxybutyrate on cognition in memory-impaired adults. Neurobiol Aging. 2004 Mar;25(3):311-4. doi: 10.1016/S0197-4580(03)00087-3.
PubMed 15123336
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study of Tricaprilin (AC-1202) Administered For Ninety Days In Subjects With Age-Associated Memory Impairment
- ClinicalTrials.gov ID
- NCT00355550
- Acronym / sponsor ID
- KET-06-003
- Conditions
- Age-Associated Memory Impairment
- Keywords
- Mild Cognitive Impairment, Cognition disorders, nutritional supplement, dietary supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- CerecinIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 24 Jul 2006 (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 purpose of this study is to determine whether tricaprilin, a compound that increases energy availability in the brain, improves memory in older adults with "normal" loss of memory abilities since early adult life.
Detailed description
One physiological hallmark of aging in mammals is a decreased uptake and metabolism of glucose within the brain. The impaired glucose metabolism in the brain may contribute or exacerbate the cognitive deficits observed during normal aging. Facilitation of memory in elderly individuals occurs when glucose levels are elevated by the administration of carbohydrate. However, such a treatment poses challenges since elevated blood glucose levels are difficult to maintain and must be within a relatively narrow window, as excessive hyperglycemia is associated with cognitive impairments. The purpose of this study is to explore whether increasing levels of other substrates for the brain improves cognitive functioning in normal aged individuals with memory disorders.
Study participants will be 120 men and women aged 50-85 who have been diagnosed as having Age-Associated Memory Impairment (AAMI). During the double-blind period of the protocol, 60 participants will receive tricaprilin and 60 participants will receive a matching placebo. Tricaprilin or the matching placebo will be administered once a day for ninety days by mixing powder in 8 ounces of a liquid. Each participant will be seen six (6) times: at Screening; Baseline; treatment days Days 30, 60, 90; and 14 days after the conclusion of treatment (Day 104).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC-1202 | Active comparator | Drug: TricaprilinTricaprilin formulation, once daily. Administered orally |
| Matching Placebo to AC-1202 | Placebo comparator | Other: PlaceboPlacebo formulation, once daily. Administered orally |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Complaints that memory has declined since young adult life
- Scores on standardized tests that are at least one standard deviation below the mean score of young adults
Key exclusion criteria (3 listed)
- Dementia, including Alzheimer's disease and Mild Cognitive Impairment (MCI)
- Drugs that impair cognition
- Psychiatric conditions that may impair cognition (e.g.,depression 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-1202Powder formulation will be mixed in a liquid (approximately 8 oz). | Drug | AC-1202 |
| PlaceboAlso: Matching placebo to AC-1202Powder formulation will be mixed in a liquid (approximately 8 oz). | Other | Matching Placebo to AC-1202 |
Primary outcome
Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test)
Time frame: 90 days
Number of subjects with treatment related adverse events
Time frame: 90 days
AE incidence rate per treatment group
1 secondary outcome
Self-reported memory improvement
Time frame: 90 days
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 18 Sep 2020.
- Background: PubMed 15123336Reger MA, Henderson ST, Hale C, Cholerton B, Baker LD, Watson GS, Hyde K, Chapman D, Craft S. Effects of beta-hydroxybutyrate on cognition in memory-impaired adults. Neurobiol Aging. 2004 Mar;25(3):311-4. doi: 10.1016/S0197-4580(03)00087-3.
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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.
Samuel Henderson, PhD study chair
Cerecin
Thomas H. Crook III, PhD principal investigator
Psychologix, Inc.
Thomas Hochadel, Pharm.D. study director
Advanced Research Corporation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tricaprilin in people with Age-Associated Memory Impairment, run by Cerecin at 6 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 2 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: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test) (time frame: 90 days). 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?
On the ClinicalTrials.gov record for NCT00355550, which also lists 1 linked publication.
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 18 Sep 2020.