Alzheimer´s DiseasePhase 2NCT00608946
Treatment With Copper in Patients With Mild Alzheimer´s Dementia
A Phase 2 study testing copper in people with Alzheimer´s Disease, run by University Hospital, Saarland.
Trial summary
The efficacy of 8 mg of copper daily regarding cognitive function, content of beta amyloid protein in the CSF and volumetric changes in the brain will be examined in a first double-blind, placebo-controlled human clinical trial conducted in 70 patients with mild Alzheimer´s dementia. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer´s Disease
- What is being tested?
- copper
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Aug 2007
- Phase
- Phase 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- male or female patients
- between 50 and 80 years
- criteria of mild dementia
- probable Alzheimer´s dementia according to NINCDS-ADRDA criteria
- given written informed consent
- having a relative who can fill out questionnaire; caregiver consent
- free of serious and unstable somatic illness
Who cannot join
- unable to give informed consent
- unable to take cholinesterase inhibitors
- unapproved medication
- moderate to severe Alzheimer´s disease
- dementia of other etiology
- history of alcohol, drug or medication abuse
Show all 15Show fewer
- other psychiatric disorder, e. g. schizophrenia
- known copper and zinc storage disease
- known copper and zinc intolerance
- vegans
- known severe allergies or intolerances
- insufficient knowledge of the German language
- female patients of childbearing potential, pregnant or nursing patients
- participation in a clinical trial within the past 30 days before onset of this study
- severe somatic diseases and high mortality rate AST, ALT, GGT, GLDH, AP or bilirubin being a two-fold above the normal range
About this study
The efficacy of 8 mg of copper daily regarding cognitive function, content of beta amyloid protein in the CSF and volumetric changes in the brain will be examined in a first double-blind, placebo-controlled human clinical trial conducted in 70 patients with mild Alzheimer´s dementia.
- Conditions
- Alzheimer´s Disease
- Being tested
- copper, placebo
- Keywords
- efficacy of treatment with copper in patients with mild Alzheimer´s disease, cognitive status over time, CSF and volumetric data over time (1 year)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
copperDietary supplement
intake of copper orotate 8 mg per day per os, once daily for one year, vs. placebo under observation of the cognitive status
placeboDietary supplement
placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | efficacy of the intake of 8 mg of copper daily per os for one year under observation of cognitive status unless unacceptable side effects appear Receives: Dietary Supplement: copper |
| 2 | Placebo comparator | placebo Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of cognitive function, measured by ADAS-cog
Measured: one year
Secondary outcomes (1)
change of beta amyloid in the CSF and volumetric changes in the brain
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2008 (estimated)
- Study startMar 2004
- Primary completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer´s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany
- Investigators
- Frank G Pajonk, M.D., lecturer, Principal investigator, Dept. of Psychiatry and Psychotherapy, The Saarland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00608946
- Sponsor's protocol ID
- UKS-PSY-DEM-01
- Other IDs
- UKS-PSY-DEM-01
- Status last verified
- Jan 2008
- First submitted
- 23 Jan 2008
- Last updated
- 6 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bayer TA, Schafer S, Simons A, Kemmling A, Kamer T, Tepest R, Eckert A, Schussel K, Eikenberg O, Sturchler-Pierrat C, Abramowski D, Staufenbiel M, Multhaup G. Dietary Cu stabilizes brain superoxide dismutase 1 activity and reduces amyloid Abeta production in APP23 transgenic mice. Proc Natl Acad Sci U S A. 2003 Nov 25;100(24):14187-92. doi: 10.1073/pnas.2332818100. Epub 2003 Nov 14.
PubMed 14617773
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Copper in Patients With Mild Alzheimer´s Dementia
- ClinicalTrials.gov ID
- NCT00608946
- Acronym / sponsor ID
- UKS-PSY-DEM-01
- Conditions
- Alzheimer´s Disease
- Keywords
- efficacy of treatment with copper in patients with mild Alzheimer´s disease, cognitive status over time, CSF and volumetric data over time (1 year)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Collaborators
- University of Goettingen, Section Neurobiology (Head: Prof. Dr. T. Bayer), Germany
- Study start
- Mar 2004
- Primary completion
- Aug 2007 (actual)
- First posted
- 6 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The efficacy of 8 mg of copper daily regarding cognitive function, content of beta amyloid protein in the CSF and volumetric changes in the brain will be examined in a first double-blind, placebo-controlled human clinical trial conducted in 70 patients with mild Alzheimer´s dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: copperefficacy of the intake of 8 mg of copper daily per os for one year under observation of cognitive status unless unacceptable side effects appear |
| 2 | Placebo comparator | Dietary Supplement: placeboplacebo |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- male or female patients
- between 50 and 80 years
- criteria of mild dementia
- probable Alzheimer´s dementia according to NINCDS-ADRDA criteria
- given written informed consent
Key exclusion criteria (15 listed)
- unable to give informed consent
- unable to take cholinesterase inhibitors
- unapproved medication
- moderate to severe Alzheimer´s disease
- dementia of other etiology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| copperintake of copper orotate 8 mg per day per os, once daily for one year, vs. placebo under observation of the cognitive status | Dietary supplement | 1 |
| placeboplacebo | Dietary supplement | 2 |
Primary outcome
change of cognitive function, measured by ADAS-cog
Time frame: one year
1 secondary outcome
change of beta amyloid in the CSF and volumetric changes in the brain
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2008.
- Background: PubMed 14617773Bayer TA, Schafer S, Simons A, Kemmling A, Kamer T, Tepest R, Eckert A, Schussel K, Eikenberg O, Sturchler-Pierrat C, Abramowski D, Staufenbiel M, Multhaup G. Dietary Cu stabilizes brain superoxide dismutase 1 activity and reduces amyloid Abeta production in APP23 transgenic mice. Proc Natl Acad Sci U S A. 2003 Nov 25;100(24):14187-92. doi: 10.1073/pnas.2332818100. Epub 2003 Nov 14.
- Dept. of Neurobiology, University of Goettingen (Head: Prof. Dr. T. Bayer)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank G Pajonk, M.D., lecturer principal investigator
Dept. of Psychiatry and Psychotherapy, The Saarland University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing copper in people with Alzheimer´s Disease, run by University Hospital, Saarland.
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 7 inclusion and 15 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: finished, as of the sponsor's last update on 6 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change of cognitive function, measured by ADAS-cog (time frame: one year). 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 NCT00608946, which also lists 1 linked publication.
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 6 Feb 2008.