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Sponsored by: |
Accera, Inc. |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00355550 |
The purpose of this study is to determine whether Ketasyn, a compound that increases energy availability in the brain, improves memory in older adults with “normal” loss of memory abilities since early adult life.
Condition | Intervention | Phase |
---|---|---|
Age-Associated Memory Impairment |
Drug: Ketasyn |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled Study of Ketasyn (AC-1202) Administered For Ninety Days In Subjects With Age-Associated Memory Impairment |
Estimated Enrollment: | 150 |
Study Start Date: | July 2006 |
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 Ketasyn™, and 60 participants will receive a matching placebo. Ketasyn™ 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).
Ages Eligible for Study: | 50 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
Meridien Research | |
Brooksville, Florida, United States, 34613 | |
Anchor Research Center | |
Naples, Florida, United States, 34102 | |
Renstar Medical Research | |
Ocala, Florida, United States, 34471 | |
Meridien Research | |
St. Petersburg, Florida, United States, 33709 | |
University Clinical Research Center | |
Pembroke Pines, Florida, United States, 33024 | |
University Clinical Research-DeLand | |
Deland, Florida, United States, 32720 |
Study Chair: | Samuel Henderson, PhD | Accera, Inc. |
Principal Investigator: | Thomas H. Crook III, PhD | Psychologix, Inc. |
Study Director: | Thomas Hochadel, Pharm.D. | Advanced Research Corporation |
Study ID Numbers: | IA0094, KET-06-003 |
Study First Received: | July 20, 2006 |
Last Updated: | June 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00355550 History of Changes |
Health Authority: | United States: Institutional Review Board |
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