Status:
COMPLETED
Efficacy and Safety of Talsaclidine in Patients With Mild to Moderate Dementia of Alzheimer Type
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Alzheimer Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief Summary
The objective of this trial was to assess the dose-response relationship of symptomatic efficacy of talsaclidine base on ADAScog and to assess safety and tolerability
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT02249403
Start Date
January 1 1999
Last Update
September 26 2014
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