<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02248116</url>
  </required_header>
  <id_info>
    <org_study_id>506.208</org_study_id>
    <nct_id>NCT02248116</nct_id>
  </id_info>
  <brief_title>Follow-up Trial to Assess the Long-term Safety and Tolerability of Talsaclidine in Patients With Mild to Moderate Dementia of the Alzheimer Type</brief_title>
  <official_title>An Open-label Multicentre, Follow-up Trial to Assess the Long-term Safety and Tolerability of Oral Administration of Talsaclidine 24 mg Tid in Patients With Mild to Moderate Dementia of the Alzheimer Type</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <brief_summary>
    <textblock>
      Safety and tolerability. Quality of life (EQ-5D, ACQLI) and health economic impact (health&#xD;
      resource utilisation, living and employment status) assessments, will not be performed at the&#xD;
      centers in the united kingdom (UK)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <start_date>May 1999</start_date>
  <primary_completion_date type="Actual">September 2000</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with adverse events</measure>
    <time_frame>Up to 17 month after first drug administration</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients with abnormal changes in laboratory tests</measure>
    <time_frame>Up to 17 month after first drug administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in neuropsychiatric inventory scores</measure>
    <time_frame>Up to 17 month after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in clinical global impression (CGI)/ clinical global impression of change scores</measure>
    <time_frame>Up to 17 month after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in mini mental state scores</measure>
    <time_frame>Up to 17 month after first drug administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life by EuroQol (EQ-5D) score</measure>
    <time_frame>Up to 17 month after first drug administration</time_frame>
    <description>not to be performed in the United Kingdom</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of healthy economic impact by healthy resource utilisation, living and employment status changes</measure>
    <time_frame>Up to 17 month after first drug administration</time_frame>
    <description>not to be performed in the United Kingdom</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Alzheimer carer quality of life instrument (ACQLI) scores</measure>
    <time_frame>Up to 17 month after first drug administration</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">198</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Alzheimer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Talsaclidine</intervention_name>
    <arm_group_label>Alzheimer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient met the inclusion criteria for the preceding talsaclidine trial&#xD;
&#xD;
          -  Patient completed the preceding talsaclidine trial within the last four weeks with&#xD;
             adequate compliance&#xD;
&#xD;
          -  Patient is able to understand the patient information and give written informed&#xD;
             consent in accordance with GCP (good clinical practice) and local legislation. In case&#xD;
             of doubt, a study independent physician should assess the patient. If in the opinion&#xD;
             of study independent physician the patient is unable to provide written inform&#xD;
             consent, a legal guardian may provide consent on behalf of the patient&#xD;
&#xD;
          -  Patient has a relative or caregiver who has given written informed consent to provide&#xD;
             trial related information for self and patient and is willing and capable of&#xD;
             supporting the clinical trial&#xD;
&#xD;
          -  Patient and caregiver are able to complete the trial examinations, to hear, speak,&#xD;
             read and write in a basic way and primary sensorial function are intact&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient developed a medical condition during the preceding talsaclidine trial which,&#xD;
             in the opinion of the investigator may be worsened by participation in this trial&#xD;
&#xD;
          -  Patient experienced any serious drug related adverse event (s) in the preceding&#xD;
             talsaclidine trial&#xD;
&#xD;
          -  Patient dropped out of the preceding talsaclidine trial&#xD;
&#xD;
          -  Patient was a major protocol violator in the preceding talsaclidine trial&#xD;
&#xD;
          -  Untreated or non-compensated hypertension (BP systolic &gt; 180 and/or diastolic &gt; 110&#xD;
             mmHg)&#xD;
&#xD;
          -  Hypertension being treated with ß-blockers&#xD;
&#xD;
          -  Severe heart failure (NYHA: III and IV)&#xD;
&#xD;
          -  Any arrhythmias including bradycardia with a rate of &lt;50 bpm, arrhythmias due to&#xD;
             second or third degree blocks and low II-IV, ECG &lt;30 ventricular extra systoles/hour,&#xD;
             multifocal or multiform and repetitive forms of ventricular extra systoles&#xD;
&#xD;
          -  Bronchial asthma with phases of exacerbation or inducible by aspirin or other NSAIDSs&#xD;
&#xD;
          -  Any patient with diabetes, type I or II, under active treatment with either insulin or&#xD;
             any oral agent&#xD;
&#xD;
          -  Renal insufficiency: calculated creatinine clearance below normal range (based on&#xD;
             gender, age and weight)&#xD;
&#xD;
          -  Acute hepatic disorder (liver enzymes above 50% upper normal limit)&#xD;
&#xD;
          -  Patient has obvious symptoms of dehydration&#xD;
&#xD;
          -  Neoplasm currently active or likely to recur (except basal cell carcinoma, squamous&#xD;
             cell carcinoma of the skin and clinically significant meningioma)&#xD;
&#xD;
          -  Patient is participating in another clinical trial&#xD;
&#xD;
          -  Pregnant and lactating women, women of childbearing potential not using an approved&#xD;
             method of contraception&#xD;
&#xD;
          -  Insufficient compliance: in the investigator's opinion the patient or caregiver are&#xD;
             unable to comply with the protocol requirements&#xD;
&#xD;
          -  Exclude subjects with less than 50 kg body weight and/or with a calculated creatinine&#xD;
             clearance below 50 ml/min. (It will be calculated by the central laboratory - values&#xD;
             below normal range will be flagged by the central laboratory)&#xD;
&#xD;
          -  Patients with abnormal urinalysis results such as infection or proteinuria as defined&#xD;
             by:&#xD;
&#xD;
               -  A positive urinary bacterial culture, equal or greater than 10exp5 colony forming&#xD;
                  unit (CFU)/ml or&#xD;
&#xD;
               -  More than 10 leukocytes per high power field and with more than &gt; 2 granular&#xD;
                  casts per low power field or&#xD;
&#xD;
               -  More than 10 red blood cells per high power field or&#xD;
&#xD;
               -  &gt;+1 proteinuria (equivalent to &gt;30 mg/dl) and with a ratio of urine protein/urine&#xD;
                  creatinine &gt;0.3&#xD;
&#xD;
          -  Any patient with a history of chronic urinary tract infection or recent urinary tract&#xD;
             infection over the past six months. If the patient developed a lower urinary tract&#xD;
             infection during their participation in the study 506.203 without any sign of kidney&#xD;
             failure, then they are allowed to enter the study. Patients may continue in the trial&#xD;
             only if the infection is confined to the lower urinary tract and without any sign of&#xD;
             kidney failure, but must be discontinued otherwise&#xD;
&#xD;
          -  Patients with a history of renal stones within the past six months&#xD;
&#xD;
        Concomitant Therapy exclusion&#xD;
&#xD;
          -  Benzodiazepines (brotizolam, oxazepam, temazepam, or triazolam are allowed)&#xD;
&#xD;
          -  Antidepressants including all tricyclics (trazodone is allowed; for clinically&#xD;
             relevant depressed mood the Selective Serotonine Re-uptake Inhibitors (SSRIs)&#xD;
             fluoxetine or paroxetine or sertraline are allowed)&#xD;
&#xD;
          -  Antipsychotics (haloperidol or risperidone are allowed)&#xD;
&#xD;
          -  Anticholinergics (topical application and promethazine is allowed)&#xD;
&#xD;
          -  Lithium&#xD;
&#xD;
          -  Acetylcholinesterase inhibitors&#xD;
&#xD;
          -  Monoamine oxidase inhibitors&#xD;
&#xD;
          -  ß blockers including topical application&#xD;
&#xD;
          -  Any concomitant therapy with significant nephrotoxic potential in case of urinary&#xD;
             tract infection (e.g. aminoglycoside, antibiotics and/or radiographic contrast agents)&#xD;
&#xD;
          -  Hypericum perforatum (St John's wort) is excluded&#xD;
&#xD;
          -  Use of neuroleptics within the trial: If the use of any neuroleptic is required during&#xD;
             the course of the trial, the reason should be documented as an adverse event and the&#xD;
             use of such medication should be limited. Use of neuroleptics should be stopped as&#xD;
             soon as the patient's clinical status allows this to happen&#xD;
&#xD;
          -  Patients receiving cognitive training prior to study entry are not excluded, but the&#xD;
             training should be continued, if possible, throughout the trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://trials.boehringer-ingelheim.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 22, 2014</last_update_submitted>
  <last_update_submitted_qc>September 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02248116
org study id: 506.208
nct id: NCT02248116
lead sponsor: 
Safety and tolerability. Quality of life (EQ-5D, ACQLI) and health economic impact (health
      resource utilisation, living and employment status) assessments, will not be performed at the
      centers in the united kingdom (UK)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with adverse events
time frame: Up to 17 month after first drug administration
measure: Number of patients with abnormal changes in laboratory tests
time frame: Up to 17 month after first drug administration
measure: Changes in neuropsychiatric inventory scores
time frame: Up to 17 month after first drug administration
measure: Changes in clinical global impression (CGI)/ clinical global impression of change scores
time frame: Up to 17 month after first drug administration
measure: Changes in mini mental state scores
time frame: Up to 17 month after first drug administration
measure: Changes in quality of life by EuroQol (EQ-5D) score
time frame: Up to 17 month after first drug administration
description: not to be performed in the United Kingdom
measure: Assessment of healthy economic impact by healthy resource utilisation, living and employment status changes
time frame: Up to 17 month after first drug administration
description: not to be performed in the United Kingdom
measure: Changes in Alzheimer carer quality of life instrument (ACQLI) scores
time frame: Up to 17 month after first drug administration
arm group label: Alzheimer
arm group type: Experimental
intervention type: Drug
intervention name: Talsaclidine
arm group label: Alzheimer
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
url: http://trials.boehringer-ingelheim.com
description: Related Info
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia