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

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. Identifier: NCT01099332
Recruitment Status : Unknown
Verified January 2011 by Adeona Pharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : April 7, 2010
Last Update Posted : January 28, 2011
Information provided by:
Adeona Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Mild Cognitive Impairment Other: Gastro-retentive zinc cysteine tablet Other: Tablet identical physically to active comparator containing some lactose Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2011

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 Name: 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 Name: Placebo Tablet

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01099332

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United States, Florida
Neuroscience Research Unit
Clearwater, Florida, United States, 33756
ATIT Neurology
Holiday, Florida, United States, 34691
The Cottages
Port Richey, Florida, United States, 34668
Sponsors and Collaborators
Adeona Pharmaceuticals
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Study Director: David Newsome, M.D. Senior Vice President of Research and Development, Adeona Pharmaceuticals, Inc.
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Responsible Party: Diana Pollock, M.D., P.I., Neurology Research Unit of Clearwater FL Identifier: NCT01099332    
Other Study ID Numbers: CopperProof-2
First Posted: April 7, 2010    Key Record Dates
Last Update Posted: January 28, 2011
Last Verified: January 2011
Keywords provided by Adeona Pharmaceuticals:
Alzheimer's disease
Mild Cognitive Impairment
Copper metabolism
Zinc metabolism
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders