Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease.
- Conditions
- HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney.MedDRA version: 9.1Level: HLTClassification code 10001897Term: Alzheimer's disease (incl subtypes)
- Registration Number
- EUCTR2005-005791-32-SE
- Lead Sponsor
- Hunter-Fleming Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
1. Mild/moderate dementia as evidenced by a screening Mini-Mental State Examination (MMSE) score of 12-24 inclusive
2. Capable of understanding written procedures and giving written informed consent.
3. Male and Female outpatients with Alzheimer’s disease The diagnosis should be established in accordance with the NINCDS-ADRDA classification for probable Alzheimer’s disease. Patients living in residential homes for the elderly will be excluded
4. Patients aged over 55 years
5. Patients who live with or have at least daily visits from a responsible carer
This includes a friend or relative. The carer should be capable of assisting with the patient’s medication, prepared to attend with the patient for assessment and willing to provide information about the patient. There may be more than one carer, however, the same carer should assess the patient throughout the study, wherever possible. If there is a local requirement, the responsible carer will sign the carer informed consent form confirming they are willing to help the patient during the study and willing to visit with them for each assessment
6. Written informed consent
Written consent should be obtained from the patient and responsible carer and countersigned by the responsible physician
7. Depending on the biomarker results from Plan A, a decision will be made whether or not to include a biomarker as an entry criterion for Plan B. If a biomarker inclusion criterion is required, it will only be added after approval as a substantial protocol amendment.
8. A negative screen for drugs of abuse, serum hepatitis B surface antigens, and hepatitis C
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Primary, secondary or pseudo- dementias
2. Concomitant medication, such as antipsychotics, anti-Parkinson’s drugs, anticonvulsants, cholinergic agents, NSAIDs, or Over-The-Counter medication other than approved by the Investigator
3. Excessive alcohol intake, malnourishment, use of antioxidant supplements; active smokers
4. Women of child-bearing potential or nursing mothers
5. Patients otherwise unsuitable for this study type, or feeling unable to comply with the restrictions required by the study
(The full list is given in Section 7.3 of the Study Protocol)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method