Overview

This trial is active, not recruiting.

Conditions alzheimer's disease, mild cognitive impairment
Treatments gastro-retentive zinc cysteine tablet, tablet identical physically to active comparator containing some lactose
Phase phase 1/phase 2
Sponsor Adeona Pharmaceuticals
Start date November 2009
End date January 2011
Trial size 60 participants
Trial identifier NCT01099332, CopperProof-2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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.
gastro-retentive zinc cysteine tablet Zinthionein ZC
Oral, one tablet, once daily with water for 6 months.
(Placebo Comparator)
Once daily administration of placebo of identical physical appearance to that of active comparator with similar amount of water.
tablet identical physically to active comparator containing some lactose Placebo Tablet
Oral, once daily, with water, 6 months.

Primary Outcomes

Measure
Biometal levels will be measured in serum by atomic absorption spectrometry
time frame: 6 to 12 months

Secondary Outcomes

Measure
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
Comparison of mental status functions at baseline, 3 and 6 months in active comparator versus placebo groups.
time frame: 6 to 12 months

Eligibility Criteria

Male or female participants from 55 years up to 90 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Adeona Pharmaceuticals.