Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2026-01-29 @ 6:38 PM
Study NCT ID:
NCT02249403
Status:
COMPLETED
Last Update Posted:
2014-09-26
First Post:
2014-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Talsaclidine in Patients With Mild to Moderate Dementia of Alzheimer Type
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 362}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-25', 'studyFirstSubmitDate': '2014-09-23', 'studyFirstSubmitQcDate': '2014-09-23', 'lastUpdatePostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2000-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change in Alzheimer's Disease Assessment Scale cognitive part (ADAScog)", 'timeFrame': 'Baseline, week 12'}], 'secondaryOutcomes': [{'measure': 'Change in ADAScog (extension)', 'timeFrame': 'Baseline, week 4, 8 and 12', 'description': 'measures cognitive capability'}, {'measure': 'Change in ADAScog (Total)', 'timeFrame': 'Baseline, week 4, 8 and 12', 'description': 'Defined as ADAScog + ADAScog (Extension)'}, {'measure': 'Change in mini mental state (MMS)', 'timeFrame': 'Screening, week 12'}, {'measure': 'Change in neuropsychiatric inventory (NPI)', 'timeFrame': 'Baseline, week 12', 'description': 'measures behavioural symptoms'}, {'measure': 'Change in Hamilton Depression Rating Scale', 'timeFrame': 'Screening, week 12', 'description': 'measures depressive mood'}, {'measure': 'Change in instrumental activity of daily living (IADL)', 'timeFrame': 'Baseline, week 12', 'description': 'measures functional performance'}, {'measure': 'Change in living status rated on a 6-point verbal rating scale', 'timeFrame': 'Baseline, week 12'}, {'measure': "Change in clinician's global impression rated with Alzheimer's Disease cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)", 'timeFrame': 'Baseline, week 12'}, {'measure': 'Number of patients with adverse events', 'timeFrame': 'up to 12 months'}]}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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)\n* Patient's educational level is \\> 4 years\n* Patient is able to understand the patient information and give informed consent\n* Patient has given written informed consent in accordance with Good Clinical Practice and local legislation\n* Patient has a non-demented relative or care giver who is willing to support the clinical trial; his/her written informed consent is optional\n* Body weight: within +/- 30% of normal weight (Broca index)\n* Diagnosis of DAT by the National Institute of Neurological and communicative Disorders-Alzheimer's Disease and Related Disorder Association (NINCDS-ADRDA) criteria\n* MMS-score 10 - 24 inclusive\n* Rosen ischemia score is lower or equal to two\n* Patient is able to complete the trial examinations, to hear, speak, read and write in a basic way and primary sensorial functions are intact\n\nExclusion Criteria:\n\n* Any dementia of vascular genesis (excluded by Rosen ischemia score \\> 2)\n* 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\n* Any stroke history\n* All secondary dementia (exclusion diagnosis defined by the NINCDS-ADRDA criteria) as a late complication of:\n\n * Cranio-cerebral trauma\n * Intoxication (incl. history of alcohol and drug abuse)\n * Cerebral infections (e.g. neurosyphilis)\n * Thyroid dysfunction\n* Cerebral dysfunction due to metabolic disorders (e.g. unstable thyroid dysfunction, or unstable insulin-dependent diabetes mellitus with hypo-/hyper-glycemic episodes)\n* Deficiency of vitamin B12 or folic acid as a reason of dementia\n* Brain tumour (A patient with an incidental tumour found on CT not felt to be clinically relevant may be included, i.e.: meningioma)\n* Down's syndrome, Parkinsonism, Huntington's chorea\n* Multiple sclerosis\n* Major depression defined by the Hamilton Depression Rating Scale (HAMD) 17 item scale (≥ 16)\n* Depressive pseudo dementia\n* Mental retardation\n* Hydrocephalus\n* Epilepsy\n* Endogenous psychoses (schizophrenia)\n* Untreated or non-compensated hypertension (Blood Pressure systolic \\> 180 and/or diastolic \\> 110 mmHg)\n* 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)\n* Severe heart failure (NYHA: III and IV)\n* Arrhythmias (Lown: II-IV, Electrocardiogram \\> 30 ventricular extrasystoles/hour, multifocal or multiform and repetitive forms of ventricular extrasystoles)\n* Bronchial asthma with phases of exacerbation or inducible by aspirin or other Nonsteroidal anti-inflammatory drugs\n* 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\n* Renal insufficiency: calculated creatinine clearance is less than 60 ml/min\n* Acute hepatic disorder (liver enzymes above 50 % upper normal limit)\n* 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)\n* Recent history of liver disease (2 years) including drug intoxication (e.g. narcotics, cytostatics etc.)\n* Patients with obvious symptoms of dehydration\n* 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)\n* Neoplasm currently active or likely to recur (except basal cell carcinoma)\n* Participation in another clinical trial within the last four weeks and re-entering from this or a previous talsaclidine trial\n* Pregnant and lactating woman, woman with childbearing potential not using an approved method of contraception\n* Insufficient compliance: in the investigator's opinion the patient or family is unable to comply with the protocol requirements"}, 'identificationModule': {'nctId': 'NCT02249403', 'briefTitle': 'Efficacy and Safety of Talsaclidine in Patients With Mild to Moderate Dementia of Alzheimer Type', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '506.203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Talsaclidine, 6 mg tid', 'interventionNames': ['Drug: Talsaclidine 6 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Talsaclidine, 12 mg tid', 'interventionNames': ['Drug: Talsaclidine 12 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Talsaclidine, 24 mg tid', 'interventionNames': ['Drug: Talsaclidine 24 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Talsaclidine, 36 mg tid', 'interventionNames': ['Drug: Talsaclidine 36 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Talsaclidine, 36 mg bid', 'interventionNames': ['Drug: Talsaclidine 36 mg', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Talsaclidine 6 mg', 'type': 'DRUG', 'armGroupLabels': ['Talsaclidine, 6 mg tid']}, {'name': 'Talsaclidine 12 mg', 'type': 'DRUG', 'armGroupLabels': ['Talsaclidine, 12 mg tid']}, {'name': 'Talsaclidine 24 mg', 'type': 'DRUG', 'armGroupLabels': ['Talsaclidine, 24 mg tid']}, {'name': 'Talsaclidine 36 mg', 'type': 'DRUG', 'armGroupLabels': ['Talsaclidine, 36 mg bid', 'Talsaclidine, 36 mg tid']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo', 'Talsaclidine, 36 mg bid']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}