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Alzheimer DiseasePhase 2/3NCT02248116

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

A Phase 2/3 study testing Talsaclidine in people with Alzheimer Disease, run by Boehringer Ingelheim.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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) Read more about this study

Who is it for?
Any age
Conditions the study is for
Alzheimer Disease
What is being tested?
Talsaclidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
No sites listed yet
Study dates
May 1999to Sep 2000
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patient met the inclusion criteria for the preceding talsaclidine trial
  • 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

Who cannot join

  • 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
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  • 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
  • Pregnant and lactating women, women of childbearing potential not using an approved method of contraception
  • Insufficient compliance: in the investigator's opinion the patient or caregiver are unable to comply with the protocol requirements
  • Exclude subjects with less than 50 kg body weight and/or with a calculated creatinine clearance below 50 ml/min. (It will be calculated by the central laboratory - values below normal range will be flagged by the central laboratory)
  • Patients with abnormal urinalysis results such as infection or proteinuria as defined by:
  • A positive urinary bacterial culture, equal or greater than 10exp5 colony forming unit (CFU)/ml or
  • More than 10 leukocytes per high power field and with more than > 2 granular casts per low power field or
  • More than 10 red blood cells per high power field or
  • >+1 proteinuria (equivalent to >30 mg/dl) and with a ratio of urine protein/urine creatinine >0.3
  • Any patient with a history of chronic urinary tract infection or recent urinary tract infection over the past six months. If the patient developed a lower urinary tract infection during their participation in the study 506.203 without any sign of kidney failure, then they are allowed to enter the study. Patients may continue in the trial only if the infection is confined to the lower urinary tract and without any sign of kidney failure, but must be discontinued otherwise
  • Patients with a history of renal stones within the past six months
  • Concomitant Therapy exclusion
  • Benzodiazepines (brotizolam, oxazepam, temazepam, or triazolam are allowed)
  • Antidepressants including all tricyclics (trazodone is allowed; for clinically relevant depressed mood the Selective Serotonine Re-uptake Inhibitors (SSRIs) fluoxetine or paroxetine or sertraline are allowed)
  • Antipsychotics (haloperidol or risperidone are allowed)
  • Anticholinergics (topical application and promethazine is allowed)
  • Lithium
  • Acetylcholinesterase inhibitors
  • Monoamine oxidase inhibitors
  • ß blockers including topical application
  • Any concomitant therapy with significant nephrotoxic potential in case of urinary tract infection (e.g. aminoglycoside, antibiotics and/or radiographic contrast agents)
  • Hypericum perforatum (St John's wort) is excluded
  • Use of neuroleptics within the trial: If the use of any neuroleptic is required during the course of the trial, the reason should be documented as an adverse event and the use of such medication should be limited. Use of neuroleptics should be stopped as soon as the patient's clinical status allows this to happen
  • Patients receiving cognitive training prior to study entry are not excluded, but the training should be continued, if possible, throughout the trial

About this study

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

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)

Being tested
Talsaclidine
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TalsaclidineDrug

Study groups in NCT02248116
Study groupRoleWhat they receive
AlzheimerExperimentalNot described
Receives: Drug: Talsaclidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with adverse events

    Measured: Up to 17 month after first drug administration

  2. Number of patients with abnormal changes in laboratory tests

    Measured: Up to 17 month after first drug administration

Secondary outcomes (6)

  1. Changes in neuropsychiatric inventory scores

    Measured: Up to 17 month after first drug administration

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

    Measured: Up to 17 month after first drug administration

  3. Changes in mini mental state scores

    Measured: Up to 17 month after first drug administration

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

    not to be performed in the United Kingdom

    Measured: Up to 17 month after first drug administration

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

    not to be performed in the United Kingdom

    Measured: Up to 17 month after first drug administration

  6. Changes in Alzheimer carer quality of life instrument (ACQLI) scores

    Measured: Up to 17 month after first drug administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2014 (estimated)
  2. Study startMay 1999
  3. Primary completionSep 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02248116
Sponsor's protocol ID
506.208
Status last verified
Sep 2014
First submitted
22 Sep 2014
Last updated
25 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Talsaclidine in people with Alzheimer Disease, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with adverse events (time frame: Up to 17 month after first drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02248116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.

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