NCT00013923

Brief Summary

The purpose of this study is to evaluate the effectiveness of a nutritional supplement that has been developed to improve the brain function of a patient with Alzheimer's disease.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 3, 2001

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

December 11, 2009

Status Verified

August 1, 2003

First QC Date

April 2, 2001

Last Update Submit

December 10, 2009

Conditions

Alzheimer Disease

Keywords

Nutritional Supplement

Interventions

Nutritional SupplementDRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A documented diagnosis of Alzheimer's disease;
  • MMSE score between 10 and 26 inclusive;
  • A reliable caregiver to ensure compliance.

You may not qualify if:

  • diabetes, unstable medical illness, myocardial infarction or cancer diagnosed within the previous 12 months, or treatment with systemic steroids.
  • Patients being treated for depression or other psychiatric symptomatology are eligible, if their symptoms are under control on a stable dose of medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

Related Publications (3)

  • Blass JP. The mitochondrial spiral. An adequate cause of dementia in the Alzheimer's syndrome. Ann N Y Acad Sci. 2000;924:170-83. doi: 10.1111/j.1749-6632.2000.tb05576.x.

    PMID: 11193795BACKGROUND

  • Blass JP, Sheu RK, Gibson GE. Inherent abnormalities in energy metabolism in Alzheimer disease. Interaction with cerebrovascular compromise. Ann N Y Acad Sci. 2000 Apr;903:204-21. doi: 10.1111/j.1749-6632.2000.tb06370.x.

    PMID: 10818509BACKGROUND

  • Manning CA, Ragozzino ME, Gold PE. Glucose enhancement of memory in patients with probable senile dementia of the Alzheimer's type. Neurobiol Aging. 1993 Nov-Dec;14(6):523-8. doi: 10.1016/0197-4580(93)90034-9.

    PMID: 8295654BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • John P Blass, MD, PhD

    Burke Medical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 2, 2001

First Posted

April 3, 2001

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

December 11, 2009

Record last verified: 2003-08

Locations

US(1)