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Trial record 3 of 7 for:    ALZHEIMER DISEASE 14

Safety of Three Formulations of Ketasyn Administered for 14 Days in Healthy Elderly

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00660088
First Posted: April 17, 2008
Last Update Posted: October 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Accera, Inc.
  Purpose
AC-1202 (Ketasyn) is a nutritional beverage currently being studied in neurodegenerative conditions including Alzheimer's disease. The current study is a randomized, open-label trial to compare the safety, tolerability, and PK profiles of 3 formulations of Ketasyn administered on a daily basis for 14 days, with and without a 7-day titration period, in normal, healthy elderly volunteers.

Condition Intervention Phase
Alzheimer's Disease Other: Ketasyn Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tolerability, Safety, And Pharmacokinetics Of Three Formulations Of Oral Ketasyn™ (Ac-1202) Administered For Fourteen Days, With Or Without Titration, In Healthy Elderly Volunteers

Resource links provided by NLM:


Further study details as provided by Accera, Inc.:

Primary Outcome Measures:
  • Plasma peak concentration levels and AUC [ Time Frame: two weeks ]

Secondary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: 3 weeks ]

Biospecimen Retention:   Samples Without DNA
plasma beta-hydroxybutyrate

Estimated Enrollment: 60
Study Start Date: April 2008
Study Completion Date: August 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
10 gram x 7 days, then 20 gram x 7 days active ingredient of original formulation
Other: Ketasyn
10g for 7 days, 20g for 7 or 14 days
2
20 grams x 14 days active ingredient of original formulation
Other: Ketasyn
10g for 7 days, 20g for 7 or 14 days
3
10 grams x 7 days; then 20 grams x 7 days of low protein formulation
Other: Ketasyn
10g for 7 days, 20g for 7 or 14 days
4
20 grams x 14 days of low protein formulation
Other: Ketasyn
10g for 7 days, 20g for 7 or 14 days
5
10 grams x 7 days; then 20 grams x 7 days of high protein formulation
Other: Ketasyn
10g for 7 days, 20g for 7 or 14 days
6
20 grams x 14 days of high protein formulation
Other: Ketasyn
10g for 7 days, 20g for 7 or 14 days

Detailed Description:
Sixty healthy, elderly volunteers between the ages of 55 and 85 will be enrolled at one of four clinical sites in the Tampa/St. Petersburg area. Subjects with a history of GI inflammatory conditions (e.g., IBS or diverticulitis) or other clinically significant abnormalities will be excluded from enrollment. Subjects will be randomized to one of two dosing regimens (with or without a 7-day titration period) and to one of three formulations of Ketasyn containing the identical amount of active ingredient, but different amounts of proteins and carbohydrates. Subjects assigned to Group 1 will receive 10 grams active ingredient daily on Days 1-7, followed by a daily dose of 20 grams active ingredient on Days 8-14. Subjects assigned to Group 2 will receive 20 grams active ingredient on Days 1-14. All subjects will have clinic visits on Day 1 and 14; subjects assigned to Group 1 will also have a clinic visit on Day 8. Subjects will fast prior to each clinic visit and have vital signs and routine lab tests performed prior to dosing. A standard breakfast will be served along with the study product, following which blood samples will be collected for product concentration levels.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy elderly male and female subjects 55 - 85 years of age
Criteria

Inclusion Criteria:

  • No clinically significant abnormal findings on physical exam, vital signs, medical history, ECG, or laboratory results

Exclusion Criteria:

  • Type 1 or uncontrolled Type 2 diabetes
  • History of or current inflammation of GI system, e.g. IBS, diverticular disease, gastric or duodenal ulcers, severe GERD requiring daily medication
  • History (within past 60 days) of infections
  • Clinically significant renal, hepatic, or hematologic abnormalities
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660088


Locations
United States, Florida
Meridien Research Center
St. Petersburg, Florida, United States, 33709
Sponsors and Collaborators
Accera, Inc.
Investigators
Study Director: Lauren Costantini, PhD Accera, Inc.
  More Information

Responsible Party: Lauren Costantini, PhD; Vice President Clinical Development, Accera, Inc.
ClinicalTrials.gov Identifier: NCT00660088     History of Changes
Other Study ID Numbers: KET-08-004
First Submitted: April 11, 2008
First Posted: April 17, 2008
Last Update Posted: October 8, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders