Alzheimer's DiseasePhase 2NCT00130429
Safety and Effect on Memory of PYM50028 in Mild Alzheimer's Disease
A Phase 2 study testing PYM50028 in people with Alzheimer's Disease, run by Phytopharm at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the effect of PYM50028 administered once daily for up to 12 weeks on the memory and other faculties of subjects with dementia due to Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- PYM50028
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2004to Sep 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 50 years of age
- Diagnosis of possible or probable Alzheimer's disease
- Mini mental state examination score at least 16
- Good understanding of both written and verbal English
- A recent head scan that is consistent with the diagnosis of Alzheimer's disease
Who cannot join
- Recent history or clinical evidence of significant neurological disease other than dementia due to Alzheimer's disease
- Known to have another condition that is associated with dementia
- Use of psychotropic medication within the previous 4 weeks (excluding cholinesterase inhibitors, selective serotonin reuptake inhibitors and venlafaxine)
- Hormone replacement therapy started or changed within the previous 6 months
- Received any investigational drugs within the previous 12 weeks
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Project to Investigate Memory and Ageing
Oxford, Oxfordshire, OX3 7JX
About this study
Official title: Phase II Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Investigate the Safety, Effect on Cognition and Pharmacokinetic Profile of PYM50028 in Subjects With Mild Dementia of the Alzheimer's Type
The purpose of this study is to assess the effect of PYM50028 administered once daily for up to 12 weeks on the memory and other faculties of subjects with dementia due to Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- PYM50028
- Keywords
- dementia, memory, Hopkins verbal learning test, paired associated learning
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PYM50028Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hopkins verbal learning test (revised) total word recall after 12 weeks
Cambridge neuropsychological test automated battery (CANTAB) paired associate learning (Phytopharm modified form) total adjusted error score after 12 weeks
Secondary outcomes (7)
Mini mental state examination score
Clinical dementia rating (overall and sum of boxes)
CANTAB rapid visual information processing (RVIP) mean latency
CANTAB RVIP total correct hits
CANTAB spatial working memory within error, between error and strategy scores
Clinicians global impression of change
Disability assessment for dementia score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startJan 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Enrolment
- 250 participants
Sponsor and investigators
- Lead sponsor
- Phytopharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robin Jacoby, FRCPsych, Principal investigator, University of Oxford, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130429
- Sponsor's protocol ID
- P58/09ME/03/04
- Status last verified
- Aug 2009
- First submitted
- 12 Aug 2005
- Last updated
- 21 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomised, Double Blind, Placebo Controlled, Parallel Group Study to Investigate the Safety, Effect on Cognition and Pharmacokinetic Profile of PYM50028 in Subjects With Mild Dementia of the Alzheimer's Type
- ClinicalTrials.gov ID
- NCT00130429
- Acronym / sponsor ID
- P58/09ME/03/04
- Conditions
- Alzheimer's Disease
- Keywords
- dementia, memory, Hopkins verbal learning test, paired associated learning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- PhytopharmIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Sep 2005 (actual)
- First posted
- 15 Aug 2005 (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 purpose of this study is to assess the effect of PYM50028 administered once daily for up to 12 weeks on the memory and other faculties of subjects with dementia due to Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 50 years of age
- Diagnosis of possible or probable Alzheimer's disease
- Mini mental state examination score at least 16
- Good understanding of both written and verbal English
- A recent head scan that is consistent with the diagnosis of Alzheimer's disease
Key exclusion criteria (5 listed)
- Recent history or clinical evidence of significant neurological disease other than dementia due to Alzheimer's disease
- Known to have another condition that is associated with dementia
- Use of psychotropic medication within the previous 4 weeks (excluding cholinesterase inhibitors, selective serotonin reuptake inhibitors and venlafaxine)
- Hormone replacement therapy started or changed within the previous 6 months
- Received any investigational drugs within the previous 12 weeks
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 |
|---|---|---|
| PYM50028 | Drug | – |
Primary outcome
Hopkins verbal learning test (revised) total word recall after 12 weeks
Cambridge neuropsychological test automated battery (CANTAB) paired associate learning (Phytopharm modified form) total adjusted error score after 12 weeks
7 secondary outcomes
Mini mental state examination score
Clinical dementia rating (overall and sum of boxes)
CANTAB rapid visual information processing (RVIP) mean latency
CANTAB RVIP total correct hits
CANTAB spatial working memory within error, between error and strategy scores
Clinicians global impression of change
Disability assessment for dementia score
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 21 Aug 2009.
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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.
Robin Jacoby, FRCPsych principal investigator
University of Oxford, UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PYM50028 in people with Alzheimer's Disease, run by Phytopharm at 1 site in United Kingdom.
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 5 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 21 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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?
Hopkins verbal learning test (revised) total word recall after 12 weeks. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2009.