CompletedPhase 2

Efficacy and Safety of Talsaclidine in Patients With Mild to Moderate Dementia of Alzheimer Type

Efficacy and Safety of 6, 12, 24, and 36 mg Tid po and 36 mg Bid po Talsaclidine (Free Base) for 12 Weeks in a Double-blind, Randomised, Placebo-controlled Parallel Group Comparison in Patients With Mild to Moderate Dementia of Alzheimer Type

Lead sponsor

Boehringer Ingelheim

Asset

Talsaclidine

Listed sites

Recruiting sites

Enrollment

362

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

•ADAS-Cog

Identifiers

Registered as

Org study ID506.203

NCT IDNCT02249403

Timeline

Milestones

Study start1999-01 (month precision)

Primary completion2000-01actual (month precision)

Study first posted2014-09-25estimated

Last update posted2014-09-26estimated

Assets

Drug assets

Talsaclidine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age40 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female patient, age: over 40 years (lower age if genetic Dementia of Alzheimer Type (DAT) is documented. Patients over 85 years need to be in a clinically stable state (investigator's judgement)

•Patient's educational level is > 4 years

•Patient is able to understand the patient information and give informed consent

•Patient has given written informed consent in accordance with Good Clinical Practice and local legislation

•Patient has a non-demented relative or care giver who is willing to support the clinical trial; his/her written informed consent is optional

•Body weight: within +/- 30% of normal weight (Broca index)

•Diagnosis of DAT by the National Institute of Neurological and communicative Disorders-Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria

•MMS-score 10 - 24 inclusive

•Rosen ischemia score is lower or equal to two

•Patient is able to complete the trial examinations, to hear, speak, read and write in a basic way and primary sensorial functions are intact

Exclusion criteria

•Any dementia of vascular genesis (excluded by Rosen ischemia score > 2)

•Magnetic Resonance Imaging (MRI) or Computer Tomogram (CT) (more recent than 12 months; if a MRI of CT recording is performed more than 12 months before study entry, it must be repeated) findings make the diagnosis of DAT unlikely

•Any stroke history

•All secondary dementia (exclusion diagnosis defined by the NINCDS-ADRDA criteria) as a late complication of:

-Cranio-cerebral trauma

-Intoxication (incl. history of alcohol and drug abuse)

-Cerebral infections (e.g. neurosyphilis)

-Thyroid dysfunction

•Cerebral dysfunction due to metabolic disorders (e.g. unstable thyroid dysfunction, or unstable insulin-dependent diabetes mellitus with hypo-/hyper-glycemic episodes)

•Deficiency of vitamin B12 or folic acid as a reason of dementia

•Brain tumour (A patient with an incidental tumour found on CT not felt to be clinically relevant may be included, i.e.: meningioma)

•Down's syndrome, Parkinsonism, Huntington's chorea

•Multiple sclerosis

•Major depression defined by the Hamilton Depression Rating Scale (HAMD) 17 item scale (≥ 16)

•Depressive pseudo dementia

•Mental retardation

•Hydrocephalus

•Epilepsy

•Endogenous psychoses (schizophrenia)

•Untreated or non-compensated hypertension (Blood Pressure systolic > 180 and/or diastolic > 110 mmHg)

•Hypertension being treated with reserpine, clonidine or β-blockers (these cases have to be adjusted to therapy with e.g. calcium antagonists 4 weeks before start of treatment)

•Severe heart failure (NYHA: III and IV)

•Arrhythmias (Lown: II-IV, Electrocardiogram > 30 ventricular extrasystoles/hour, multifocal or multiform and repetitive forms of ventricular extrasystoles)

•Bronchial asthma with phases of exacerbation or inducible by aspirin or other Nonsteroidal anti-inflammatory drugs

•Severe diabetes mellitus: insulin dependent and not stabilised (patient with an HbA1c in normal range, clinically stable diabetes and any case of insulin dose ≤ 0.5 UI/kg/day may be included), or other metabolic diseases

•Renal insufficiency: calculated creatinine clearance is less than 60 ml/min

•Acute hepatic disorder (liver enzymes above 50 % upper normal limit)

•Chronic hepatitis within the last two years (positive hepatitis titer, Hepatitis A Virus, Hepatitis B Virus, Hepatitis C Virus, cytomegalovirus, Epstein-Barr virus or abnormal immunological values (positive immunoglobulin M(IgM)/IgG) are allowed if all liver enzymes are within the normal range)

•Recent history of liver disease (2 years) including drug intoxication (e.g. narcotics, cytostatics etc.)

•Patients with obvious symptoms of dehydration

•History of drug or alcohol abuse or dependence on other hepatotoxic agents (if a patient is permanently hospitalised and a drug screen performed at the beginning of hospitalisation, no additional drug screen is necessary)

•Neoplasm currently active or likely to recur (except basal cell carcinoma)

•Participation in another clinical trial within the last four weeks and re-entering from this or a previous talsaclidine trial

•Pregnant and lactating woman, woman with childbearing potential not using an approved method of contraception

•Insufficient compliance: in the investigator's opinion the patient or family is unable to comply with the protocol requirements

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

Other (unclassified)

Safety / tolerability / PK

Other clinical outcomes

Global cognition

4 endpoints

Primary/protocol endpoint

Change in Alzheimer's Disease Assessment Scale cognitive part (ADAScog)

Time frame:Baseline, week 12

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in ADAScog (extension)

Time frame:Baseline, week 4, 8 and 12

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in ADAScog (Total)

Time frame:Baseline, week 4, 8 and 12

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Change in mini mental state (MMS)

Time frame:Screening, week 12

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change in neuropsychiatric inventory (NPI)

Time frame:Baseline, week 12

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Change in Hamilton Depression Rating Scale

Time frame:Screening, week 12

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of patients with adverse events

Time frame:up to 12 months

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Change in clinician's global impression rated with Alzheimer's Disease cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)

Time frame:Baseline, week 12

change from baseline, improvement

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change in instrumental activity of daily living (IADL)

Time frame:Baseline, week 12

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in living status rated on a 6-point verbal rating scale

Time frame:Baseline, week 12

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.