Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease
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| ClinicalTrials.gov Identifier: NCT01354691 |
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Recruitment Status :
Completed
First Posted : May 17, 2011
Last Update Posted : July 23, 2013
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Sponsor:
Avraham Pharmaceuticals Ltd
Information provided by (Responsible Party):
Avraham Pharmaceuticals Ltd
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease Dementia Memory Loss Cognitive Impairment | Drug: ladostigil hemitartrate | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 201 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A 6-Month Prospective, Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Adaptive-Trial-Design Study to Evaluate the Safety and Efficacy of 80mg b.i.d Ladostigil in Patients With Mild to Moderate Probable Alzheimer's Disease With a 6-Month Open Label Follow-Up Period |
| Study Start Date : | February 2011 |
| Actual Primary Completion Date : | September 2012 |
| Actual Study Completion Date : | March 2013 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
| Arm | Intervention/treatment |
|---|---|
| Experimental: ladostigil hemitartrate |
Drug: 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. |
Primary Outcome Measures :
- ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale [ Time Frame: 26 weeks ]11 item, unmodified ADAS-Cog (total possible score of 70)
- Safety Evaluation [ Time Frame: 6,15 26, 39 and 52 week assessment of safety and tolerability ]Number and severity of adverse events across trial period.
Secondary Outcome Measures :
- Neuropsychiatric Inventory (NPI) [ Time Frame: 6, 15, 26, 39 and 52 weeks ]Assessment of behavioral and psychological symptoms of disease
- Cornell Scale for Depression in Dementia (CSDD) [ Time Frame: 6, 15, 26, 39 and 52 weeks ]Assessment of depressive status
- Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 6, 15, 26, 39 and 52 weeks ]Assessment of functional activity status
- Mini-Mental State Examination (MMSE) [ Time Frame: 6, 15, 26, 39 and 52 weeks ]Secondary assessment of cognitive status utilizing common metric
- ADAS-Cog: Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: 6, 15, 39 and 52 weeks ]11 item, unmodified ADAS-Cog (total possible score of 70)
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| Ages Eligible for Study: | 60 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354691
Locations
| Austria | |
| Medizinische Univeritat Graz, Universitatsklinik fur Neurologie, Auenbruggerplatz 22 | |
| Graz, Austria, 8036 | |
| Privatordination Horn, HamerlingstraBe 15 | |
| Horn, Austria, 3580 | |
| Allgemeines Krankenhaus der Stadt Linz, KrankenhausstraBe 9 | |
| Linz, Austria, 4020 | |
| Privatordination, Lainzerstrasse 20 | |
| Wein, Austria, 1130 | |
| Croatia | |
| General Hospital Pula, Negrijeva 6 | |
| Pula, Croatia, 52100 | |
| General Hospital Zabok, Bracak 8 | |
| Zabok, Croatia, 49210 | |
| Clinical Hospital Center Zagreb, Kispaticeva 12 | |
| Zagreb, Croatia, 10000 | |
| Clinical Hospital Dubrava, Avenija Gojka Suska 6 | |
| Zagreb, Croatia, 10000 | |
| Polyclinic Neuron, Salata 12 | |
| Zagreb, Croatia, 10000 | |
| Psychiatric Hospital Vrapce, Bolnicka cesta 32 | |
| Zagreb, Croatia, 10090 | |
| Germany | |
| Klinische Forschung Hamburg GmbH, Hoheluftaussee 18 | |
| Hanburg, Germany, 20253 | |
| Klinische Forschung Schwerin GmbH, FriedrichstraBe 1 | |
| Schwerin, Germany, 19055 | |
| Studienzentrum Nordwest, Lange StraBe 23-25 | |
| Westerstede, Germany, 26655 | |
| Serbia | |
| Clinical Centre of Serbia, Dr. Subotica 6 | |
| Beograd, Serbia, 11000 | |
| Military Medical Academy, Crnotravska 17 | |
| Beograd, Serbia, 11000 | |
| Spain | |
| CAE Oroitu Centro Atencion Especializada C/Jata, 9 | |
| Algorta (Vizcaya), Spain, 48993 | |
| Centro Geroinnova Barcelona, Calle Mandoni n 17 | |
| Barcelona, Spain, 08004 | |
| Fundacio ACE, Institut Catala de Neurosciencies Aplicadas, C/Margues de Sentmenat 35-37 | |
| Barcelona, Spain, 08014 | |
| Institud d' Assistencia Sanitaria de Girona, Edifici La Republica - C/Dr. Castany, s/n | |
| SALT (Girona), Spain, 17190 | |
Sponsors and Collaborators
Avraham Pharmaceuticals Ltd
Investigators
| Principal Investigator: | Reinhold Schmidt, MD | MEDIZINISCHE UNIVERSITAT GRAZ |
| Responsible Party: | Avraham Pharmaceuticals Ltd |
| ClinicalTrials.gov Identifier: | NCT01354691 History of Changes |
| Other Study ID Numbers: |
CR100101/CO15570 |
| First Posted: | May 17, 2011 Key Record Dates |
| Last Update Posted: | July 23, 2013 |
| Last Verified: | July 2013 |
Keywords provided by Avraham Pharmaceuticals Ltd:
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Alzheimer's Disease Dementia Memory Loss Cognitive Impairment Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Depression Anxiety |
Additional relevant MeSH terms:
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Alzheimer Disease Dementia Cognitive Dysfunction Memory Disorders Amnesia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms |