- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02249351
Efficacy and Safety of Talsaclidine (Free Base) in Patients With Mild to Moderate Dementia of Alzheimer Type
September 25, 2014 updated by: Boehringer Ingelheim
Efficacy and Safety of 48 mg Talsaclidine (Free Base) Tid po (Panel 1) and 60 mg Talsaclidine (Free Base) Tid po (Panel 2) for 12 Weeks in a Double-blind, Randomised, Placebo-controlled Within Escalating Dose Panels in 150 Patients With Mild to Moderate Dementia of Alzheimer Type
Study to assess symptomatic efficacy, safety and tolerability of talsaclidine in patients with mild to moderate dementia of Alzheimer type
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 relative or caregiver who is willing and capable to support the clinical trial; his/her written informed consent is optional
- Body weight: ≥ 50 kg and 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 (Rosen ischemia score > 2)
- Magnetic Resonance Imaging (MRI) or Computer Tomogram (CT) findings make the diagnosis of DAT unlikely (with a scan performed within 12 months of study entry)
- 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
- Possible reversible dementias secondary to a deficiency of vitamin B12, folic acid or thyroid hormone. Replacement therapy must be started three months before visit 1 in order to exclude dementia due to these deficiencies.
- Brain tumour (benign tumours found on CT not felt to be clinically relevant may be included, i.e.: meningioma)
- Down's syndrome, Parkinson's disease, Huntington's chorea, Diffuse Lewy Body Disease (as measured by the McKeith Criteria and specified in CTM)
- Multiple sclerosis
- Major depression with a score of <=16 on the Hamilton Depression Rating Scale (HAMD) 17 item scale
- Depressive pseudodementia
- Mental retardation
- Hydrocephalus
- Epilepsy
- Endogenous psychoses (schizophrenia)
- Untreated or poorly compensated hypertension (Blood Pressure systolic > 180 and/or diastolic > 110 mmHg)
- Hypertension being treated with reserpine, clonidine or β-blockers
- Severe heart disease (NYHA: III and IV)
- Any cardiac arrhythmias (atrial or ventricular) including bradycardia with a rate of < 50 bpm, arrhythmias due to second or third degree blocks and Lown: II-IV, Electrocardiogram > 30 ventricular extrasystoles/hour, multifocal or multiform and repetitive forms of ventricular extrasystoles, pacemakers are allowed
- Bronchial asthma with phases of exacerbation, or inducible by aspirin or other Nonsteroidal anti-inflammatory drugs, requiring acute pharmacologic intervention during the previous year
- Diabetes, type I or II, under active treatment with either insulin or an oral agent, diabetes controlled by diet and exercise alone is not excluded
- Renal insufficiency with a calculated creatinine clearance of less than 50 ml/min
Abnormal urinalysis results as defined by:
- a bacterial colony count of greater than 100,000/ml or
- more than 10 leukocytes per high power field with more than 2 granular casts per low power field or
- more than 10 red blood cells per high power field or
- proteinuria >+ 1 (equivalent to > 30 mg/dl) and with a ratio of urine protein/urine creatinine > 0.3
- History of chronic urinary tract infection or recent urinary tract infection over the past six months
- History of renal stones within the past six months
- 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)
- History of liver disease within 2 years secondary to drug intoxication of any cause including drug intoxication (e.g. narcotics, cytostatics etc.)
- Patients with obvious symptoms of dehydration
- Abuse or dependence on drugs or other hepatotoxic agents by history or drug screen. A history of alcohol abuse within the last 10 years will also exclude the patient
- Neoplasm currently active or likely to recur, or in need of treatment (except basal cell carcinoma)
- Participation in another clinical trial within the last four weeks, or previous participation in a talsaclidine trial; patients who have been entered into panel 1 are not eligible for inclusion in panel 2
- Pregnant and lactating woman, woman with childbearing potential not using an approved method of contraception
- Poor ability of the patient or caregiver/family to comply with protocol requirements as assessed by the investigator
- A list of excluded medications is attached to the protocol. These medications have to be replaced at least four weeks before the trial medication is started. If replacement in not clinically advisable, then the patient has to be excluded from the trial
In Germany, patients with the following additional diagnosis are excluded
- manifest angina pectoris as well as
- peripheral arterial circulatory disturbances
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: Talsaclidine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in Alzheimer's Disease Assessment Scale cognitive part (ADAScog)
Time Frame: Baseline, week 4, 8, 12
|
Baseline, week 4, 8, 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with adverse events
Time Frame: up to 6 months
|
up to 6 months
|
|
Change in ADAScog (extension)
Time Frame: Baseline, week 4, 8, 12
|
Baseline, week 4, 8, 12
|
|
Change in ADAScog (Total)
Time Frame: Baseline, week 4, 8, 12
|
Defined as ADAScog + ADAScog(extension)
|
Baseline, week 4, 8, 12
|
Change in mini mental state (MMS)
Time Frame: Screening, week 12
|
Screening, week 12
|
|
Change in neuropsychiatric inventory (NP)
Time Frame: Baseline, week 12
|
Baseline, week 12
|
|
Change in Hamilton Depression Rating Scale (HAMD 17 item scale)
Time Frame: Screening, week 12
|
Screening, week 12
|
|
Change in instrumental activity of daily living (IADL)
Time Frame: Baseline, week 12
|
Baseline, week 12
|
|
Change in living status rated on a 6-point scale
Time Frame: Baseline, week 12
|
Baseline, week 12
|
|
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
|
Baseline, week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 1999
Primary Completion (Actual)
May 1, 2000
Study Registration Dates
First Submitted
September 23, 2014
First Submitted That Met QC Criteria
September 23, 2014
First Posted (Estimate)
September 25, 2014
Study Record Updates
Last Update Posted (Estimate)
September 26, 2014
Last Update Submitted That Met QC Criteria
September 25, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 506.209
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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