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

NCT01354691 | Completed Phase 2 Results DMC

• 1 other identifier: CR100101/CO15570
• Study Type: interventional
• Target: 200
• Locations: 5 countries
• Sites: 19

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale

  Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia, The ADAS-Cog consist of 11 questions: Word Recall Task Naming Objects and Fingers Following Commands Constructional Praxis Ideational Praxis Orientation Word Recognition Task Remembering Test Directions Spoken Language Comprehension Word-Finding Difficulty Item scores are summed. Low total scores indicate better cognitive performance. Minimum score 0 is best and maximum is 70 - worst. For the purposes of analyses the change from baseline is computed to each administration of the test.

  26 weeks

Secondary Outcomes (4)

• Neuropsychiatric Inventory (NPI)

  52 weeks

• Cornell Scale for Depression in Dementia (CSDD)

  52 weeks

• Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

  52 weeks

• Mini-Mental State Examination

  52 weeks

Study Arms (2)

ladostigil hemitartrate

EXPERIMENTAL

Ladostigil capsules 80 mg

Drug: ladostigil hemitartrate

Placebo

PLACEBO COMPARATOR

Placebo capsules

Drug: ladostigil hemitartrate

Interventions

ladostigil hemitartrate 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; ladostigil hemitartrate

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avraham Pharmaceuticals Ltd: lead

Study Sites (19)

Medizinische Univeritat Graz, Universitatsklinik fur Neurologie, Auenbruggerplatz 22

Graz, 8036, Austria

Location

Privatordination Horn, HamerlingstraBe 15

Horn, 3580, Austria

Location

Allgemeines Krankenhaus der Stadt Linz, KrankenhausstraBe 9

Linz, 4020, Austria

Location

Privatordination, Lainzerstrasse 20

Wein, 1130, Austria

Location

General Hospital Pula, Negrijeva 6

Pula, 52100, Croatia

Location

General Hospital Zabok, Bracak 8

Zabok, 49210, Croatia

Location

Clinical Hospital Center Zagreb, Kispaticeva 12

Zagreb, 10000, Croatia

Location

Clinical Hospital Dubrava, Avenija Gojka Suska 6

Zagreb, 10000, Croatia

Location

Polyclinic Neuron, Salata 12

Zagreb, 10000, Croatia

Location

Psychiatric Hospital Vrapce, Bolnicka cesta 32

Zagreb, 10090, Croatia

Location

Klinische Forschung Hamburg GmbH, Hoheluftaussee 18

Hamburg, 20253, Germany

Location

Klinische Forschung Schwerin GmbH, FriedrichstraBe 1

Schwerin, 19055, Germany

Location

Studienzentrum Nordwest, Lange StraBe 23-25

Westerstede, 26655, Germany

Location

Clinical Centre of Serbia, Dr. Subotica 6

Belgrade, 11000, Serbia

Location

Military Medical Academy, Crnotravska 17

Belgrade, 11000, Serbia

Location

CAE Oroitu Centro Atencion Especializada C/Jata, 9

Algorta, 48993, Spain

Location

Centro Geroinnova Barcelona, Calle Mandoni n 17

Barcelona, 08004, Spain

Location

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

Barcelona, 08014, Spain

Location

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

Salt, 17190, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Memory Disorders; Cognitive Dysfunction; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Tauopathies; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Jonathan Rabinowitz, PhD
• Organization: Bar Ilan University

jonathan.rabinowitz@biu.ac.il

Study Officials

• Reinhold Schmidt, MD

  MEDIZINISCHE UNIVERSITAT GRAZ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2011
• First Posted: May 17, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: March 1, 2013
• Last Updated: July 30, 2020
• Results First Posted: July 30, 2020

Record last verified: 2018-07

Locations

ES (4); SE (2); DE (3); AU (4); CR (6)