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Alzheimer's DiseasePhase 1/2NCT01099332

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

A Phase 1/2 study testing Gastro-retentive zinc cysteine tablet and Tablet identical physically to active comparator containing some lactose in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Adeona Pharmaceuticals at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 55 to 90 years
What is being tested?
Gastro-retentive zinc cysteine tablet and Tablet identical physically to active comparator containing some lactose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
3 sitesUnited States
Study dates
Nov 2009to Jan 2011
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Neuroscience Research Unit

    Clearwater, Florida, 33756

  • ATIT Neurology

    Holiday, Florida, 34691

  • The Cottages

    Port Richey, Florida, 34668

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Gastro-retentive zinc cysteine tablet, Tablet identical physically to active comparator containing some lactose
Keywords
Alzheimer's disease, Mild Cognitive Impairment, Copper metabolism, Zinc metabolism, Ceruloplasmin
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gastro-retentive zinc cysteine tabletOther

    Also called Zinthionein ZC

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

  • Tablet identical physically to active comparator containing some lactoseOther

    Also called Placebo Tablet

    Oral, once daily, with water, 6 months.

Study groups in NCT01099332
Study groupRoleWhat they receive
Gastro-retentive zinc cysteine tabletActive comparatorOnce daily administration by mouth of a gastro-retentive, sustained-release preparation of zinc cysteine with excipients, all G.R.A.S., with adequate water.
Receives: Other: Gastro-retentive zinc cysteine tablet
Identical appearance of placebo with active comparatorPlacebo comparatorOnce daily administration of placebo of identical physical appearance to that of active comparator with similar amount of water.
Receives: Other: Tablet identical physically to active comparator containing some lactose

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 to 12 months

Secondary outcomes (2)

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

    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

    Measured: 3 months

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

    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.

    Measured: 6 to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2010 (estimated)
  2. Study startNov 2009
  3. Primary completionJan 2011 (estimated)
  4. Study completionJan 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01099332
Sponsor's protocol ID
CopperProof-2
Status last verified
Jan 2011
First submitted
30 Mar 2010
Last updated
28 Jan 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19122030

  • 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.

    PubMed 20026314

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Gastro-retentive zinc cysteine tablet and Tablet identical physically to active comparator containing some lactose in people with Alzheimer's Disease and Mild Cognitive Impairment, run by Adeona Pharmaceuticals at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biometal levels will be measured in serum by atomic absorption spectrometry (time frame: 6 to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01099332, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2011.

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