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Ketasyn In Age-Associated Memory Impairment
This study has been completed.
First Received: July 20, 2006   Last Updated: June 18, 2007   History of Changes
Sponsored by: Accera, Inc.
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00355550
  Purpose

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

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test)

Secondary Outcome Measures:
  • Self-reported memory improvement

Estimated Enrollment: 150
Study Start Date: July 2006
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 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).

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Dementia, including Alzheimer’s disease and Mild Cognitive Impairment (MCI)
  • Drugs that impair cognition
  • Psychiatric conditions that may impair cognition (e.g.,depression etc.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00355550

Locations
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
Sponsors and Collaborators
Accera, Inc.
Investigators
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
  More Information

Publications:
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

Keywords provided by National Institute on Aging (NIA):
Mild Cognitive Impairment
Cognition disorders
nutritional supplement
dietary supplement

Study placed in the following topic categories:
Signs and Symptoms
Neurologic Manifestations
Neurobehavioral Manifestations
Memory Disorders
Cognition Disorders

Additional relevant MeSH terms:
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Neurobehavioral Manifestations
Memory Disorders

ClinicalTrials.gov processed this record on September 11, 2009