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.
Conditions
Interventions
Product Name: HF0220
Product Code: HF0220
Pharmaceutical Form: Powder for oral suspension
Current Sponsor code: HF0220
Other descriptive
Sponsors
Hunter-Fleming Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 classification1 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of HF0220 in a patient population. ; Secondary Objective: To validate biochemical markers relevant to Alzheimer's disease as appropriate end-points in a future chronic clinical study of the neuroprotective effect of HF0220 in patients with a diagnosis of mild-to-moderate Alzheimer's Disease. To assess the suitability of chosen dose levels for future studies. ;Primary end point(s): Candidate dose level and validation of biochemical markers indicative of HF0220 action. | — |
Countries
Sweden, United Kingdom
Outcome results
None listed