Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-1202 | Active Comparator | Tricaprilin formulation, once daily. Administered orally |
|
| Matching Placebo to AC-1202 | Placebo Comparator | Placebo formulation, once daily. Administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tricaprilin | Drug | Powder formulation will be mixed in a liquid (approximately 8 oz). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test) | 90 days | |
| Number of subjects with treatment related adverse events | AE incidence rate per treatment group | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported memory improvement | 90 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Samuel Henderson, PhD | Cerecin | Study Chair |
| Thomas H. Crook III, PhD | Psychologix, Inc. | Principal Investigator |
| Thomas Hochadel, Pharm.D. | Advanced Research Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meridien Research | Brooksville | Florida | 34613 | United States | ||
| University Clinical Research-DeLand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15123336 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C003637 | tricaprylin |
| C538853 | AC-1202 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Powder formulation will be mixed in a liquid (approximately 8 oz). |
|
|
| DeLand |
| Florida |
| 32720 |
| United States |
| Anchor Research Center | Naples | Florida | 34102 | United States |
| Renstar Medical Research | Ocala | Florida | 34471 | United States |
| University Clinical Research Center | Pembroke Pines | Florida | 33024 | United States |
| Meridien Research | St. Petersburg | Florida | 33709 | United States |