Trial of Novel Oral Zinc Cysteine Preparation in Alzheimer's Disease
|ClinicalTrials.gov 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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
U.S. FDA Resources
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
- 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
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099332
|United States, Florida|
|Neuroscience Research Unit|
|Clearwater, Florida, United States, 33756|
|Holiday, Florida, United States, 34691|
|Port Richey, Florida, United States, 34668|
|Study Director:||David Newsome, M.D.||Senior Vice President of Research and Development, Adeona Pharmaceuticals, Inc.|