NCT01099332

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 28, 2011

Status Verified

January 1, 2011

Enrollment Period

1.2 years

First QC Date

March 30, 2010

Last Update Submit

January 27, 2011

Conditions

Alzheimer's DiseaseMild Cognitive Impairment

Keywords

Alzheimer's diseaseMild Cognitive ImpairmentCopper metabolismZinc metabolismCeruloplasmin

Outcome Measures

Primary Outcomes (1)

  • Biometal levels will be measured in serum by atomic absorption spectrometry

    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 Outcomes (2)

  • Serum zinc levels after oral administration of two different zinc-containing compounds and placebo will be determined by atomic absorption spectrometry

    3 months

  • Comparison of mental status functions at baseline, 3 and 6 months in active comparator versus placebo groups.

    6 to 12 months

Study Arms (2)

Gastro-retentive zinc cysteine tablet

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.

Other: Gastro-retentive zinc cysteine tablet

Identical appearance of placebo with active comparator

PLACEBO 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

Interventions

Gastro-retentive zinc cysteine tabletOTHER

Oral, one tablet, once daily with water for 6 months.

Also known as: Zinthionein ZC
Gastro-retentive zinc cysteine tablet
Tablet identical physically to active comparator containing some lactoseOTHER

Oral, once daily, with water, 6 months.

Also known as: Placebo Tablet
Identical appearance of placebo with active comparator

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Neuroscience Research Unit

Clearwater, Florida, 33756, United States

Location

ATIT Neurology

Holiday, Florida, 34691, United States

Location

The Cottages

Port Richey, Florida, 34668, United States

Location

Related Publications (3)

  • Squitti R, Bressi F, Pasqualetti P, Bonomini C, Ghidoni R, Binetti G, Cassetta E, Moffa F, Ventriglia M, Vernieri F, Rossini PM. Longitudinal prognostic value of serum "free" copper in patients with Alzheimer disease. Neurology. 2009 Jan 6;72(1):50-5. doi: 10.1212/01.wnl.0000338568.28960.3f.

    PMID: 19122030BACKGROUND

  • Arnal N, Cristalli DO, de Alaniz MJ, Marra CA. Clinical utility of copper, ceruloplasmin, and metallothionein plasma determinations in human neurodegenerative patients and their first-degree relatives. Brain Res. 2010 Mar 10;1319:118-30. doi: 10.1016/j.brainres.2009.11.085. Epub 2009 Dec 22.

    PMID: 20026314BACKGROUND

  • Brewer GJ, Newsome DA et al. Sub-clinical zinc deficiency found in Alzheimer's disease. Presented at ICAD, Vienna,Austria; July 2009 09-HT-2656-ALZ; submitted for publication

    BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • David Newsome, M.D.

    Senior Vice President of Research and Development, Adeona Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 30, 2010

First Posted

April 7, 2010

Study Start

November 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 28, 2011

Record last verified: 2011-01

Locations

US(3)