Alzheimer´s Disease
Conditions
Keywords
safety, GSK inhibitor, Alzheimer
Brief summary
The purpose of this study is to evaluate if 4 escalating doses during 20 weeks of NP031112 are safe and tolerated in patients with Alzheimer´s disease.
Interventions
DRUGNP031112
unidose sachets containing dry powder for oral suspension, once daily dosing 400 mg (4 to 20 weeks), 600 mg(4 to 16 weeks),800 mg (6 to 12 weeks), 1000 mg (6 weeks)
DRUGPlacebo
unidose sachets containing dry powder for oral suspension, once daily dosing 400 mg (4 to 20 weeks), 600 mg(4 to 16 weeks),800 mg (6 to 12 weeks), 1000 mg (6 weeks)
Sponsors
Noscira SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women (non-childbearing potential) with a diagnosis of probable Alzheimer's disease according to the NINCDS-ADRDA clinical criteria. 2. Age 60 - 85 years (patients over 85 years could be included after a previous assessment by the investigator and in agreement with the sponsor) 3. MRI or CT-scan assessment within 12 months before baseline corroborating the clinical diagnosis (diffuse brain atrophy predominating in medial temporal regions) and excluding other potential causes of dementia, especially cerebrovascular lesions (see
Exclusion criteria
, number 3). 4. Mild to moderate stage of Alzheimer's disease according to MMSE 16-26. 5. Modified Hachinski ischemic score equal to or below 4. 6. Geriatric Depression Scale below or equal 7. 7. Female patients must be either surgically sterilized or at least 1 year postmenopausal (confirmed by FSH \>20, for women not surgically sterilized). 8. A caregiver/nurse is available and is living in the same household, or interacts with the patient to assure the correct preparation and administration of the study drug to the patient. 9. Patients living at home or old people's home. 10. General health status acceptable for a participation in a 6 months clinical trial. 11. Ability to swallow 100 -150 ml of water suspension. 12. No daily-regular/chronic intake of medications acting on central nervous system, immunosuppressants, steroids or non-steroid anti-inflammatory agents except the following allowed treatments: * SSRIs as antidepressants if they are administered at a stable and well tolerated dose for two months prior to baseline evaluation * the following drugs at a stable and well tolerated dose to symptomatic treatment of mild behavioral disorder, sleep onset-insomnia or mild depressive mood: * Risperidon max 1mg/day * Quetiapin max 25mg/day * Zolpidem max 10mg in the evening * Lorazepam max 1mg/day * Triazolam max 0,25mg/day * Alprazolam max 1mg/day * Mirtazapin max 30mg/day * Hydromorphon max 4mg/day * Levodopa max 50mg t.i.d as treatment of an age-associated extrapyramidal syndrome or restless-legs-syndrome * Acetylsalicylic acid max 100mg/day as antiplatelet agent. * Non-steroid anti-rheumatics as concomitant medication taken per request 13. No history of treatment with Warfarin, Digitoxin or Coumarin (including its derivatives) within 1 month prior to baseline. Chronic treatment with heparin s.c. as anticoagulant or digoxin for the treatment of heart disease are allowed. 14. Other drugs metabolized by the CYP3A4 with wide therapeutic window are permitted if their dose and regimen are stable and well tolerated for at least 1 month prior to baseline. 15. Stable pharmacological treatment of any other chronic condition for at least one month prior to screening. 16. Treatment with a stable and well tolerated dose of one of the approved Acetylcholinesterase-Inhibitors (Donepezil, Galantamine or Rivastigmine) for at least 2 months prior to baseline evaluations. Dosage of Acetylcholine-esterase inhibitors should not be increased during the ongoing study. 17. No history of treatment with Memantine within 3 months prior to baseline evaluation. Patients with a stable and well tolerated dose of Memantine are not allowed to be included in the study. 18. Signed informed consent by patient prior to the initiation of any study specific procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rates and severity of clinical adverse events and lab abnormalities for each dose level and placebo | 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Effect of treatment with four doses of NP031112 on cognition and depressive mood | 20 weeks |
Countries
Germany
Outcome results
None listed