CompletedPhase 2Results posted

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

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

Lead sponsor

Avraham Pharmaceuticals Ltd

Asset

ladostigil hemitartrate

Listed sites

Recruiting sites

Enrollment

200

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 14-24

Primary endpoint

•ADAS-Cog

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDCR100101/CO15570

NCT IDNCT01354691

Timeline

Milestones

Study start2011-02 (month precision)

Study first posted2011-05-17estimated

Primary completion2012-09actual (month precision)

Study completion2013-03actual (month precision)

Last update posted2020-07-30actual

Results first posted2020-07-30actual

Assets

Drug assets

ladostigil hemitartrate

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age60 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Behavior / neuropsychiatric

Function / daily living

Global cognition

4 endpoints

Primary/protocol endpoint

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

Time frame:26 weeks

ADAS-Cog

change from baseline, improvement

Primary/registry result

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

Time frame:26 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), score on scale - baseline to endpoint	Standard deviation
Ladostigil Hemitartraten=99 Participants	-.27	5.41
Placebon=96 Participants	0.19	5.15

p<0.67ANCOVA

Secondary/protocol endpoint

Mini-Mental State Examination

Time frame:52 weeks

Mini-Mental State Examination (MMSE)

concentration, descriptive

Secondary/registry result

Mini-Mental State Examination

Time frame:52 weeks

Mini-Mental State Examination (MMSE)

concentration, descriptive

Posted result

Group	Value (mean), change in score - baseline to endpoint	Standard deviation
Ladostigil Hemitartraten=99 Participants	0.80	2.73
Placebon=96 Participants	0.60	2.59

p=.77ANCOVA

Function / daily living

2 endpoints

Secondary/protocol endpoint

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

Time frame:52 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

categorical status, descriptive

Secondary/registry result

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

Time frame:52 weeks

ADCS-Activities of Daily Living (ADCS-ADL)

categorical status, descriptive

Posted result

Group	Value (mean), score on scale - baseline to endpoint	Standard deviation
Ladostigil Hemitartraten=99 Participants	-1.88	9.54
Placebon=96 Participants	-1.57	7.72

p=0.83ANCOVA

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:52 weeks

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

Cornell Scale for Depression in Dementia (CSDD)

Time frame:52 weeks

categorical status, descriptive

Secondary/registry result

Neuropsychiatric Inventory (NPI)

Time frame:52 weeks

Neuropsychiatric Inventory (NPI)

event count, event

Posted result

Group	Value (mean), score on scale - baseline to endpoint	Standard deviation
Ladostigil Hemitartraten=99 Participants	2.51	11.27
Placebon=96 Participants	0.66	7.90

p<0.21ANCOVA

Secondary/registry result

Cornell Scale for Depression in Dementia (CSDD)

Time frame:52 weeks

categorical status, descriptive

Posted result

Group	Value (mean), score on scale - baseline to endpoint	Standard deviation
Ladostigil Hemitartraten=93 Participants	-0.08	2.81
Placebon=86 Participants	-0.45	3.28

p<0.78ANCOVA

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.