A multicentre double-blind, placebo-controlled, randomised, parallel-group study to evaluate the safety and efficacy of BGC20-1259 in patients with mild to moderate probable Alzheimer’s Disease. - BGC20-1259 Study in Alzheimer’s patients.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-003659-63-AT
• Date of registration: 05/08/2008
• Prospective Registration: Yes
• Primary sponsor: BTG International Ltd
• Public title: A multicentre double-blind, placebo-controlled, randomised, parallel-group study to evaluate the safety and efficacy of BGC20-1259 in patients with mild to moderate probable Alzheimer’s Disease. - BGC20-1259 Study in Alzheimer’s patients.
• Scientific title: A multicentre double-blind, placebo-controlled, randomised, parallel-group study to evaluate the safety and efficacy of BGC20-1259 in patients with mild to moderate probable Alzheimer’s Disease. - BGC20-1259 Study in Alzheimer’s patients.
• Date of first enrolment: 13/03/2009
• Target sample size: 240
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003659-63
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: 6 months double-blind followed by 6 months open-label If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Austria

Key inclusion & exclusion criteria

Inclusion criteria:
1. Men and women (non-childbearing potential) with a diagnosis of Alzheimer’s disease according to the NINCDS-ADRDA clinical criteria.
2. Age 60 - 85 years inclusive.
3. MRI or CT assessment within 12 months before baseline corroborating the clinical diagnosis 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 15-26 inclusive.
5. Geriatric Depression Scale below or equal 7.
6. caregiver is available and is living in the same household, or interacts with the patient at least 4 times a week.
7. Patients living at home or old people’s home without continuous nursing care.
8. If anticholinesterase treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 2).
9. If Memantine treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 2).
10. If SSRI or MAOI treatment had been prescribed, the patient must undergo a 4 week wash out period before the baseline visit (visit 2).
11. No regular intake of medications acting on central nervous system or any anti-inflammatory agents.


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:
1. Hospitalization or change of chronic concomitant medication 1 month prior to screening or during screening period.
2. Clinical, laboratory or neuroimaging findings consistent with:
• other primary degenerative dementia, (dementia with Lewy bodies, frontotemporal dementia, Huntington’s disease, Jacob-Creutzfeld Disease, Down’s syndrome, etc)
• other neurodegenerative condition (Parkinson’s disease, amyotrophic lateral sclerosis, etc.)
• cerebrovascular disease (major infarct, one strategic or multiple lacunar infarcts, extensive white matter lesions > one quarter of the total white matter)
• other central nervous system diseases (severe head trauma, tumors, subdural haematoma or other space occupying processes, etc.)
• seizure disorder
• other infectious, metabolic or systemic diseases affecting central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, serum electrolytes out of normal range, juvenile onset diabetes mellitus, etc.)
3. A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder.
4. Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias the assessment of the clinical or mental status of the patient or put the patient at special risk, such as:
• hepatic or respiratory insufficiency
•renal insufficiency (serum creatinine >2mg/dl)
• heart disease (myocardial infarction, unstable angina, heart failure, cardiomyopathy within 6 months before screening)
• bradycardia (heart beat <50/min.) or tachycardia (heart beat >95/min.)
• hypertension or hypotension requiring treatment with more than 3 drugs
• AV block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcB-interval (males >450 and females >470 msec)
• uncontrolled diabetes
• malignant tumors within the last 5 years except skin malignancies (other than melanoma) or indolent prostate cancer
• metastases
5. Women who are fertile and of child bearing potential.
6. Chronic daily drug intake of:
• antidepressants, benzodiazepines, neuroleptics or major sedatives
• antiepileptics
• anticholinergics
• nootropics (including Gingko)
• centrally active anti-hypertensive drugs (clonidine, alpha-methyl dopa, guanidine, guanfacine, …)
• opioid containing analgesics
• non steroid anti-inflammatory agents, cortico-steroids or immunosuppressants
7. Suspected or known allergy to any components of the study treatments. Known allergies, including allergy to the study drug or its constituents or known cholinomimetic hyperreactivity
8. Enrollment in another investigational study or intake of investigational drug within the previous 3 months.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Alzheimer's disease
MedDRA version: 9.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease

Intervention(s)

Product Code: BGC20-1259
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Product Code: BGC20-1259
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Product Code: BGC20-1259
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To evaluate the efficacy of BGC20-1259 (12.5 mg, 25 mg and 50 mg qd) administered for 6 months versus matched placebo

Primary end point(s): To evaluate the efficacy of BGC20-1259 (12.5 mg, 25 mg and 50 mg qd) administered for 6 months versus matched placebo based on the following end-point:
Cognitive Drug Research (CDR) battery (computer based cognitive testing battery - composite scores of Power of Attention and Quality of Episodic Memory

Secondary Objective: To evaluate the safety of BGC20-1259 (12.5 mg, 25 mg and 50 mg qd) administered for 6 months versus matched placebo.

To evaluate the pharmacokinetic profile of BGC20-1259 (12.5 mg, 25 mg and 50 mg qd) administered for 6 months.

Secondary ID(s)

BGC20-1259-04