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

Status unconfirmed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease, Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT01099332

Run by

Adeona Pharmaceuticals

People needed

60

Starts

2009-11-01

Expected to finish

2011-01-01

Last updated by the study team

2011-01-28

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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