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Alzheimer's DiseasePhase 2NCT01354691

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

A Phase 2 study testing ladostigil hemitartrate in people with Alzheimer's Disease and Dementia, run by Avraham Pharmaceuticals Ltd at 19 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 85 years
Conditions the study is for
Alzheimer's Disease, Dementia, Memory Loss
What is being tested?
ladostigil hemitartrate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
200 participants
Where
19 sitesin 5 countries
Study dates
Feb 2011to Mar 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

19 sites in 5 countries.

19 sites in 5 countries

Croatia6 sites

  • General Hospital Pula, Negrijeva 6

    Pula, 52100

  • General Hospital Zabok, Bracak 8

    Zabok, 49210

  • Clinical Hospital Center Zagreb, Kispaticeva 12

    Zagreb, 10000

  • Clinical Hospital Dubrava, Avenija Gojka Suska 6

    Zagreb, 10000

  • Polyclinic Neuron, Salata 12

    Zagreb, 10000

  • Psychiatric Hospital Vrapce, Bolnicka cesta 32

    Zagreb, 10090

Other trials in Croatia

Austria4 sites

  • Medizinische Univeritat Graz, Universitatsklinik fur Neurologie, Auenbruggerplatz 22

    Graz, 8036

  • Privatordination Horn, HamerlingstraBe 15

    Horn, 3580

  • Allgemeines Krankenhaus der Stadt Linz, KrankenhausstraBe 9

    Linz, 4020

  • Privatordination, Lainzerstrasse 20

    Wein, 1130

Other trials in Austria

Spain4 sites

  • CAE Oroitu Centro Atencion Especializada C/Jata, 9

    Algorta, 48993

  • Centro Geroinnova Barcelona, Calle Mandoni n 17

    Barcelona, 08004

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

    Barcelona, 08014

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

    Salt, 17190

Other trials in Spain

Germany3 sites

  • Klinische Forschung Hamburg GmbH, Hoheluftaussee 18

    Hamburg, 20253

  • Klinische Forschung Schwerin GmbH, FriedrichstraBe 1

    Schwerin, 19055

  • Studienzentrum Nordwest, Lange StraBe 23-25

    Westerstede, 26655

Other trials in Germany

Serbia2 sites

  • Clinical Centre of Serbia, Dr. Subotica 6

    Belgrade, 11000

  • Military Medical Academy, Crnotravska 17

    Belgrade, 11000

Other trials in Serbia

About this study

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

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

Read the 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.

Being tested
ladostigil hemitartrate
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
Medical subject headings
Alzheimer Disease, Dementia, Memory Disorders, Cognitive Dysfunction, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ladostigil hemitartrateDrug

    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.

Study groups in NCT01354691
Study groupRoleWhat they receive
ladostigil hemitartrateExperimentalLadostigil capsules 80 mg
Receives: Drug: ladostigil hemitartrate
PlaceboPlacebo comparatorPlacebo capsules
Receives: Drug: ladostigil hemitartrate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 26 weeks

Secondary outcomes (4)

  1. Neuropsychiatric Inventory (NPI)

    The Neuropsychiatric Inventory (NPI) was developed to assess psychopathology in dementia patients. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The severity and frequency of each neuropsychiatric symptom are rated on the basis of scripted questions administered to the patient's caregiver. Higher the score the more disturbed, lower score is thus better. Minimum score is 0 and maximum is 80.

    Measured: 52 weeks

  2. Cornell Scale for Depression in Dementia (CSDD)

    The Cornell Scale for Depression in Dementia (CSDD) was developed specifically to assess signs and symptoms of major depression in dementia on the basis of a semi-structured interview of a qualified informant. The CSDD evaluates a broad spectrum of depressive signs and synptoms and includes items from other depression scales. Information is obtained from interview of the caregiver as well as from direct observation and interview of the patient CSDD is a 19 item scale assessing depressive status. Higher score more depression. The scale ranges from 0-no depression to 38 maximum depression.

    Measured: 52 weeks

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

    The Activities of Daily Living ADCS-ADL is a caregiver-based ADL scale composed of 23 items developed for use in dementia clinical trials. It is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests as well as making judgments and decisions. For each ADL, the caregiver is asked whether the patient attempted the activity during the past four weeks. If the answer is positive, the caregiver is then asked to choose the single most accurate definition of the patient's level of performance. Assessment of functional activity status is a 23 item scale measuring impairment in functioning. The scale total score ranges from 0-profound impairment to 30 normal functioning (no impairments)

    Measured: 52 weeks

  4. Mini-Mental State Examination

    The MMSE is a frequently used screening instrument for AD drug studies. The instrument provides for evaluation of orientation, memory, attention, concentration, naming, repetition, comprehension, ability to create a sentence and to copy two intersecting polygons. This examination is frequently used by physicians in the original diagnosis of AD, and in its subsequent progression, because it can be easily performed in the routine care of patients. A lower score indicates more cognitive impairment. The highest (best) score is 30. The Mini-Mental State Examination, MMSE, is a 30-point questionnaire measures cognitive impairment to screen for dementia. Items are totaled. The scale ranges from 0-most impairment to 30 (normal) no impairment.

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2011 (estimated)
  2. Study startFeb 2011
  3. Primary completionSep 2012
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01354691
Sponsor's protocol ID
CR100101/CO15570
Status last verified
Jul 2018
First submitted
1 May 2011
Last updated
30 Jul 2020
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ladostigil hemitartrate in people with Alzheimer's Disease and Dementia, run by Avraham Pharmaceuticals Ltd at 19 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Croatia, Austria, Spain, Germany, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01354691.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.

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