Alzheimer's DiseasePhase 2NCT00357357
European Study of HF0220 in Mild to Moderate Alzheimer's Disease Patients
A Phase 2 study testing HF0220 in people with Alzheimer's Disease, run by Hunter-Fleming Ltd at 10 sites in 3 countries.
Trial summary
The purpose of this Phase II study is to evaluate the safety and tolerability of HF 0220 in patients with Alzheimer's disease compared to placebo (inactive substance). The study will also validate biochemical markers as appropriate clinical end-points and to assess the suitability of chosen dose levels for future… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- HF0220
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 10 sitesin 3 countries
- Study dates
- Jul 2006to Aug 2008
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet the following inclusion criteria to be eligible.
- Male or Female (age over 55 years). Females must be non-child-bearing potential. Male patients with female partners of child-bearing potential should use effective contraception for the duration of the Study.
- A diagnosis of probable Alzheimer's disease established in accordance with the National Institute of Neurological and Communicative Disorders and Stroke /Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) classification.
- Severity of dementia of mild to moderate as assessed by the Mini-Mental State Examination (MMSE) score of 12-24.
- Patients must be living in the community living with or have at least daily visits from a responsible carer. The carer should be capable of assisting with the patient's medication, and prepared to attend with the patient for assessment.
- Written consent should be obtained from the patient and responsible carer.
Who cannot join
- Patients will not be eligible to participate in the study if they meet any of the following criteria:
- Primary, secondary or pseudodementias other than probable Alzheimer's disease.
- Clinically significant and/or uncontrolled condition or other significant medical disease.
- If taking medication for symptoms of dementia, the patient must be stable on therapy and have been taking these for a minimum of 3 months prior to enrolment.
- Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity.
- Non-steroidal or steroidal anti-inflammatory agents. However, patients stable on low dose aspirin (upto 300mg/day) for at least 3 month prior to enrolment will be eligible.
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- Taking anti-oxidant supplements.
- Active smokers of tobacco.
- Considered to be malnourished (body mass index <19).
- Patients in whom a lumbar puncture is contra-indicated.
Trial locations and contacts
10 sites in 3 countries.
10 sites in 3 countries
India5 sites
Manipal Hospital,
Bangalore, Karna
Madras Medical College & Government General Hospital
Chennai, Tamil Nadu
Nizam's Institute of Medical Sciences,
Hyderabaad, Panjagutta
Sree Chitra Tirunal Institute for Medical Sciences and Technology
Thiruvananthapuram, Kerala
King George Hospital
Visakhapatnam, ANDH PRAD
United Kingdom3 sites
Research Institute for Care of the Elderly
Bath, BA2 5RP
Memory Assessment and Research Centre
Southampton, SO30 3JB
Kingshill Research Centre
Swindon, SN1 4HZ
Sweden2 sites
Malmo University Hospital
Malmö, S205D2
Karolinksa Institute
Stockholm, SE14186
About this study
Official title: Clinical Safety/Tolerability of HF0220 and Its Effect on Biochemical Markers Relevant to Patients With a Diagnosis of Mild to Moderate Alzheimer' Disease
The purpose of this Phase II study is to evaluate the safety and tolerability of HF 0220 in patients with Alzheimer's disease compared to placebo (inactive substance). The study will also validate biochemical markers as appropriate clinical end-points and to assess the suitability of chosen dose levels for future clinical studies.
- Conditions
- Alzheimer's Disease
- Being tested
- HF0220
- Keywords
- Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF0220Drug
comparison of different dosages of drug
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Placebo comparator | 4x 7 day rising dose Receives: Drug: HF0220 |
| Group2 | Placebo comparator | 4x, 7 day rising dose Receives: Drug: HF0220 |
| Group3 | Placebo comparator | 28 day fixed lower dose Receives: Drug: HF0220 |
| Group4 | Placebo comparator | 28 day fixed upper dose Receives: Drug: HF0220 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients
Measured: June 2008
Secondary outcomes (2)
Validate biochemical markers relevant to Alzheimer's disease
Measured: June 2008
Assess the suitability of chosen HF0220 dose levels for future studies
Measured: June 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionAug 2008
- Study completionAug 2008
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter-Fleming Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Wilkinson, Principal investigator, Chief Principal InvestigatorNiels Andreasen, Dr, Principal investigator, Swedish Co-Ordinating Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357357
- Sponsor's protocol ID
- HF0220/003
- Other IDs
- 2005-005791-32, 2005
- Status last verified
- Aug 2008
- First submitted
- 26 Jul 2006
- Last updated
- 21 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pringle AK, Schmidt W, Deans JK, Wulfert E, Reymann KG, Sundstrom LE. 7-Hydroxylated epiandrosterone (7-OH-EPIA) reduces ischaemia-induced neuronal damage both in vivo and in vitro. Eur J Neurosci. 2003 Jul;18(1):117-24. doi: 10.1046/j.1460-9568.2003.02734.x.
PubMed 12859344
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety/Tolerability of HF0220 and Its Effect on Biochemical Markers Relevant to Patients With a Diagnosis of Mild to Moderate Alzheimer' Disease
- ClinicalTrials.gov ID
- NCT00357357
- Acronym / sponsor ID
- HF0220/003
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hunter-Fleming LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 27 Jul 2006 (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 Phase II study is to evaluate the safety and tolerability of HF 0220 in patients with Alzheimer's disease compared to placebo (inactive substance). The study will also validate biochemical markers as appropriate clinical end-points and to assess the suitability of chosen dose levels for future clinical studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group1 | Placebo comparator | Drug: HF02204x 7 day rising dose |
| Group2 | Placebo comparator | Drug: HF02204x, 7 day rising dose |
| Group3 | Placebo comparator | Drug: HF022028 day fixed lower dose |
| Group4 | Placebo comparator | Drug: HF022028 day fixed upper dose |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must meet the following inclusion criteria to be eligible.
- Male or Female (age over 55 years). Females must be non-child-bearing potential. Male patients with female partners of child-bearing potential should use effective contraception for the duration of the Study.
- A diagnosis of probable Alzheimer's disease established in accordance with the National Institute of Neurological and Communicative Disorders and Stroke /Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) classification.
- Severity of dementia of mild to moderate as assessed by the Mini-Mental State Examination (MMSE) score of 12-24.
- Patients must be living in the community living with or have at least daily visits from a responsible carer. The carer should be capable of assisting with the patient's medication, and prepared to attend with the patient for assessment.
Key exclusion criteria (10 listed)
- Patients will not be eligible to participate in the study if they meet any of the following criteria:
- Primary, secondary or pseudodementias other than probable Alzheimer's disease.
- Clinically significant and/or uncontrolled condition or other significant medical disease.
- If taking medication for symptoms of dementia, the patient must be stable on therapy and have been taking these for a minimum of 3 months prior to enrolment.
- Treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity.
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 |
|---|---|---|
| HF0220comparison of different dosages of drug | Drug | Group1, Group2, Group3, Group4 |
Primary outcome
Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients
Time frame: June 2008
2 secondary outcomes
Validate biochemical markers relevant to Alzheimer's disease
Time frame: June 2008
Assess the suitability of chosen HF0220 dose levels for future studies
Time frame: June 2008
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 2008.
- Background: PubMed 12859344Pringle AK, Schmidt W, Deans JK, Wulfert E, Reymann KG, Sundstrom LE. 7-Hydroxylated epiandrosterone (7-OH-EPIA) reduces ischaemia-induced neuronal damage both in vivo and in vitro. Eur J Neurosci. 2003 Jul;18(1):117-24. doi: 10.1046/j.1460-9568.2003.02734.x.
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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.
David Wilkinson principal investigator
Chief Principal Investigator
Niels Andreasen, Dr principal investigator
Swedish Co-Ordinating Principal Investigator
10 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HF0220 in people with Alzheimer's Disease, run by Hunter-Fleming Ltd at 10 sites in 3 countries.
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 6 inclusion and 10 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 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in India, United Kingdom, Sweden. 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 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?
Safety/tolerability of HF 0220 in mild to moderate Alzheimer's patients (time frame: June 2008). 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 NCT00357357, 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 21 Aug 2008.