Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease

NCT ID: NCT01354691

Last Updated: 2020-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-03-31

Brief Summary

For many, Alzheimer's disease is the number one medical issue facing our aging society. It is a late onset neurodegenerative disease, frequently under diagnosed, that impairs memory and cognitive performance. There are no known treatments that can either prevent or reverse its progression. Consequently, there still remains a need to evaluate treatments which can better stabilize the symptoms of this disease. These symptoms frequently include decreased functional capacity and negative psychological attributes (e,g, depression, anxiety) in association with the memory and cognition deficits. This current study is being done to assess an investigational compound that has been designed to not only improved the cognitive status of affected patients but to also better manage all symptoms. Hence, the ultimate goal is to provide patients with an improved quality of life by slowing the progression of this neurodegenerative disease

Detailed Description

This is a phase II, proof of concept study to evaluate the safety and efficacy of the investigational compound ladostigil versus placebo in mild to moderate Alzheimer's disease patients. The randomized, double-blind, placebo-controlled phase of the trial will be 26 weeks in duration and will involve two cohorts (i.e. one arm receiving ladostigil and one arm receiving placebo). After the initial 26 week period, all participating subjects will receive 26 weeks of treatment with ladostigil (i.e. the open label phase). A total of five territories will be participating in this trial. These include Austria, Croatia, Germany, Serbia and Spain.

Conditions

Alzheimer's Disease; Dementia; Memory Loss; Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ladostigil hemitartrate

Ladostigil capsules 80 mg

Group Type: EXPERIMENTAL

ladostigil hemitartrate

Intervention Type: DRUG

Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.

Placebo

Placebo capsules

Group Type: PLACEBO_COMPARATOR

ladostigil hemitartrate

Intervention Type: DRUG

Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.

Interventions

ladostigil hemitartrate

Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• AD diagnosis according to NINCDS-ADRDA criteria
• Mild to moderate AD according to MMSE 14-24 inclusive
• MRI or CT assessment within 6 months before baseline, corroborating the clinical diagnosis and excluding other potential causes of dementia especially cerebrovascular lesions
• Absence of major depressive disease according to CSDD of less than or equal to 18
• Modified Hachinski Ischemic Scale equal to or below 4
• Education for eight or more years
• Previous decline in cognition for more than six months as documented in patient medical records
• A caregiver available and living in the same household or interacting with the patient daily and available if necessary to assure administration of investigational product
• Patients living at home or nursing home setting without continuous nursing care
• General health status acceptable for participation in a 12-month clinical trial and ability to swallow oral medication
• No history of treatment with rivastigmine
• For patients with either donepezil or galantamine anti-cholinesterase inhibitor treatment prescribed, stopped treatment four weeks prior to screening
• For patients with memantine treatment prescribed, stopped treatment four weeks prior to screening

Exclusion Criteria

• Other primary degenerative dementias (e.g. dementia with Lewy bodies, fronto-temporal dementia, Huntington's disease, Jacob-Creutzfeldt disease)
• Other neurodegenerative conditions (Parkinson's disease. amyotrophic lateral sclerosis, etc)
• Other central nervous system diseases (severe head trauma, tumors, subdural hematoma, etc)
• A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder
• Seizure disorders
• 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)
• Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations
• Other unstable, chronic or clinically significant medical conditions involving major organs like kidney, liver, lungs and heart/vasculature
• Hospitalization or change of chronic concomitant medications one month prior to screening or during screening period

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avraham Pharmaceuticals Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reinhold Schmidt, MD

Role: PRINCIPAL_INVESTIGATOR

MEDIZINISCHE UNIVERSITAT GRAZ

Locations

Medizinische Univeritat Graz, Universitatsklinik fur Neurologie, Auenbruggerplatz 22

Graz, , Austria

Privatordination Horn, HamerlingstraBe 15

Horn, , Austria

Allgemeines Krankenhaus der Stadt Linz, KrankenhausstraBe 9

Linz, , Austria

Privatordination, Lainzerstrasse 20

Wein, , Austria

General Hospital Pula, Negrijeva 6

Pula, , Croatia

General Hospital Zabok, Bracak 8

Zabok, , Croatia

Clinical Hospital Center Zagreb, Kispaticeva 12

Zagreb, , Croatia

Clinical Hospital Dubrava, Avenija Gojka Suska 6

Zagreb, , Croatia

Polyclinic Neuron, Salata 12

Zagreb, , Croatia

Psychiatric Hospital Vrapce, Bolnicka cesta 32

Zagreb, , Croatia

Klinische Forschung Hamburg GmbH, Hoheluftaussee 18

Hamburg, , Germany

Klinische Forschung Schwerin GmbH, FriedrichstraBe 1

Schwerin, , Germany

Studienzentrum Nordwest, Lange StraBe 23-25

Westerstede, , Germany

Clinical Centre of Serbia, Dr. Subotica 6

Belgrade, , Serbia

Military Medical Academy, Crnotravska 17

Belgrade, , Serbia

CAE Oroitu Centro Atencion Especializada C/Jata, 9

Algorta, , Spain

Centro Geroinnova Barcelona, Calle Mandoni n 17

Barcelona, , Spain

Fundacio ACE, Institut Catala de Neurosciencies Aplicadas, C/Margues de Sentmenat 35-37

Barcelona, , Spain

Institud d' Assistencia Sanitaria de Girona, Edifici La Republica - C/Dr. Castany, s/n

Salt, , Spain

Countries

Austria; Croatia; Germany; Serbia; Spain

Other Identifiers

CR100101/CO15570

Identifier Type: -

Identifier Source: org_study_id