Follow-up Trial to Assess the Long-term Safety and Tolerability of Talsaclidine in Patients With Mild to Moderate Dementia of the Alzheimer Type

NCT02248116 | Terminated Phase 2

• 1 other identifier: 506.208
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

Brief Summary

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)

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

• Number of patients with adverse events

  Up to 17 month after first drug administration

• Number of patients with abnormal changes in laboratory tests

  Up to 17 month after first drug administration

Secondary Outcomes (6)

• Changes in neuropsychiatric inventory scores

  Up to 17 month after first drug administration

• Changes in clinical global impression (CGI)/ clinical global impression of change scores

  Up to 17 month after first drug administration

• Changes in mini mental state scores

  Up to 17 month after first drug administration

• Changes in quality of life by EuroQol (EQ-5D) score

  Up to 17 month after first drug administration

• Assessment of healthy economic impact by healthy resource utilisation, living and employment status changes

  Up to 17 month after first drug administration

Study Arms (1)

Alzheimer

EXPERIMENTAL

Drug: Talsaclidine

Interventions

Talsaclidine DRUG

Alzheimer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient completed the preceding talsaclidine trial within the last four weeks with adequate compliance
• Patient is able to understand the patient information and give written informed consent in accordance with GCP (good clinical practice) and local legislation. In case of doubt, a study independent physician should assess the patient. If in the opinion of study independent physician the patient is unable to provide written inform consent, a legal guardian may provide consent on behalf of the patient
• Patient has a relative or caregiver who has given written informed consent to provide trial related information for self and patient and is willing and capable of supporting the clinical trial
• Patient and caregiver are able to complete the trial examinations, to hear, speak, read and write in a basic way and primary sensorial function are intact

You may not qualify if:

• Patient developed a medical condition during the preceding talsaclidine trial which, in the opinion of the investigator may be worsened by participation in this trial
• Patient experienced any serious drug related adverse event (s) in the preceding talsaclidine trial
• Patient dropped out of the preceding talsaclidine trial
• Patient was a major protocol violator in the preceding talsaclidine trial
• Untreated or non-compensated hypertension (BP systolic \> 180 and/or diastolic \> 110 mmHg)
• Hypertension being treated with ß-blockers
• Severe heart failure (NYHA: III and IV)
• Any arrhythmias including bradycardia with a rate of \<50 bpm, arrhythmias due to second or third degree blocks and low II-IV, ECG \<30 ventricular extra systoles/hour, multifocal or multiform and repetitive forms of ventricular extra systoles
• Bronchial asthma with phases of exacerbation or inducible by aspirin or other NSAIDSs
• Any patient with diabetes, type I or II, under active treatment with either insulin or any oral agent
• Renal insufficiency: calculated creatinine clearance below normal range (based on gender, age and weight)
• Acute hepatic disorder (liver enzymes above 50% upper normal limit)
• Patient has obvious symptoms of dehydration
• Neoplasm currently active or likely to recur (except basal cell carcinoma, squamous cell carcinoma of the skin and clinically significant meningioma)
• Patient is participating in another clinical trial

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

talsaclidine fumarate

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: May 1, 1999
• Primary Completion: September 1, 2000
• Last Updated: September 25, 2014

Record last verified: 2014-09