Trial of Novel Oral Zinc Cysteine Preparation in Alzheimer's Disease

January 27, 2011 updated by: Adeona Pharmaceuticals

CopperProof-2: Prospective, Randomized, Double-Blind Placebo-Controlled Clinical Trial Comparing the Effects of a Novel Once-Daily Oral Zinc Cysteine Preparation on Zinc and Copper Parameters in Mild Cognitive Impairment and Alzheimer's Disease

This trial aims to test the hypothesis that 1) a single dose of zinc cysteine in a proprietary gastro-retentive form will produce sustained blood levels of zinc giving a larger bioavailable amount of zinc than an FDA approved preparation of inorganic zinc acetate; and 2) that the zinc cysteine gastro-retentive, sustained-release preparation will be better tolerated with significantly less gastrointestinal side effects than the zinc acetate capsules. The trial also tests the hypothesis that, after 6 months of once daily administration, the zinc cysteine subjects will show reduced serum non-ceruloplasmin copper. Additionally, subjects will perform tests of mental function,including the dementia rating scale, the Mini Mental Status Examination and the ADAS-cognitive performance test aimed at Alzheimer's status assessment. Tests will be administered at baseline, 3 and 6 months, and the performance results compared. Care-giver assessments will also be noted.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This multi-center study aims to determine the pharmacokinetics and pharmacodynamics of a novel gastro-retentive, sustained-release zinc cysteine preparation on the blood and urine measures of copper and zinc balance in Alzheimer's disease and mild cognitive impairment. Data expected to be derived include tolerability of the novel preparation in comparison with oral inorganic zinc salt, and long-term effects on primarily blood-measured copper-zinc balance. The study design is that of a prospective, randomized, double blind placebo-controlled clinical trial, with a duration for individual subjects of 6 months. The study will be performed at a total of 3 sites, under the direction of a single principal investigator, with a sub-investigator. The statistical plan calls for a comparison of data from the two long-term parallel groups using ANOVA and other applicable techniques. In addition to blood parameters, mental function assessments obtained at baseline, 3 and 6 months will be evaluated statistically.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Clearwater, Florida, United States, 33756
        • Neuroscience Research Unit
      • Holiday, Florida, United States, 34691
        • ATIT Neurology
      • Port Richey, Florida, United States, 34668
        • The Cottages

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Alzheimer's disease mild to moderate as diagnosed by standard clinical, functional and NINDA-ADRDA criteria
  • Mild cognitive impairment diagnosed by standard clinical, functional and NINDA-ADRDA criteria
  • All subjects able to swallow Tablets
  • Subjects taking copper or zinc containing supplements must have a 30-day wash out before starting study materials
  • Screening laboratory values either within normal limits or deemed not clinically significant by investigator

Exclusion Criteria:

  • Subjects or their study companions/care givers unable to give adequate informed consent
  • Presence of a disease or condition known to affect biometal homeostasis
  • Presence of psychosis, substance abuse or other major medical or neurological issues
  • Presence of vascular dementia
  • Clinically significant anemia at the time of the screening visit
  • Current use of a decoppering drug such as trientine or penicillamine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Gastro-retentive zinc cysteine tablet
Once daily administration by mouth of a gastro-retentive, sustained-release preparation of zinc cysteine with excipients, all G.R.A.S., with adequate water.
Other: Gastro-retentive zinc cysteine tablet
Oral, one tablet, once daily with water for 6 months.
Other Names:
  • Zinthionein ZC
PLACEBO_COMPARATOR: Identical appearance of placebo with active comparator
Once daily administration of placebo of identical physical appearance to that of active comparator with similar amount of water.
Other: Tablet identical physically to active comparator containing some lactose
Oral, once daily, with water, 6 months.
Other Names:
  • Placebo Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biometal levels will be measured in serum by atomic absorption spectrometry
Time Frame: 6 to 12 months
Active comparator material orally administered will be associated with better tolerability than oral zinc acetate, and will produce a reduction in serum non-ceruloplasmin bound copper levels and an elevation in serum zinc levels
6 to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum zinc levels after oral administration of two different zinc-containing compounds and placebo will be determined by atomic absorption spectrometry
Time Frame: 3 months
The change in serum zinc levels over time after oral administration of the active comparator of the study as well as the placebo and for certain subjects an inorganic zinc salt will be compared
3 months
Comparison of mental status functions at baseline, 3 and 6 months in active comparator versus placebo groups.
Time Frame: 6 to 12 months
All subjects will perform standard and standardized tests of mental function, ranging from a general dementia rating scale (Mini Mental Status Exam) to more Alzheimer's specific tests (ADAS-cognitive). Daily living and caregiver assessments of overall daily functioning will be noted. Test results will be compared statistically in a two-point fashion, and correlated with biometal ststus.
6 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adeona Pharmaceuticals

Investigators

  • Study Director: David Newsome, M.D., Senior Vice President of Research and Development, Adeona Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ANTICIPATED)

January 1, 2011

Study Completion (ANTICIPATED)

January 1, 2011

Study Registration Dates

First Submitted

March 30, 2010

First Submitted That Met QC Criteria

April 5, 2010

First Posted (ESTIMATE)

April 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2011

Last Update Submitted That Met QC Criteria

January 27, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CopperProof-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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