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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660088
• Other study ID #: KET-08-004
• Status: Completed
• Phase: Phase 1
• First received: April 11, 2008
• Last updated: October 7, 2008
• Start date: April 2008
• Est. completion date: August 2008

Study information

• Verified date: October 2008
• Source: Accera, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Other:
• Ketasyn
10g for 7 days, 20g for 7 or 14 days

Locations

Country	Name	City	State
United States	Meridien Research Center	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Accera, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma peak concentration levels and AUC		two weeks	No
Secondary	Incidence and severity of adverse events		3 weeks	Yes