Alzheimer DiseasePhase 2NCT02249403
Efficacy and Safety of Talsaclidine in Patients With Mild to Moderate Dementia of Alzheimer Type
A Phase 2 study testing Talsaclidine 6 mg, Talsaclidine 12 mg and Talsaclidine 24 mg in people with Alzheimer Disease, run by Boehringer Ingelheim.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Talsaclidine 6 mg, Talsaclidine 12 mg and Talsaclidine 24 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 362 participants
- Where
- No sites listed yet
- Study dates
- Jan 1999to Jan 2000
- Phase
- Phase 2
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 non-demented relative or care giver who is willing to support the clinical trial; his/her written informed consent is optional
- Body weight: within +/- 30% of normal weight (Broca index)
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- 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
Who cannot join
- Any dementia of vascular genesis (excluded by Rosen ischemia score > 2)
- 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
- 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)
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- Cerebral infections (e.g. neurosyphilis)
- Thyroid dysfunction
- Cerebral dysfunction due to metabolic disorders (e.g. unstable thyroid dysfunction, or unstable insulin-dependent diabetes mellitus with hypo-/hyper-glycemic episodes)
- Deficiency of vitamin B12 or folic acid as a reason of dementia
- Brain tumour (A patient with an incidental tumour found on CT not felt to be clinically relevant may be included, i.e.: meningioma)
- Down's syndrome, Parkinsonism, Huntington's chorea
- Multiple sclerosis
- Major depression defined by the Hamilton Depression Rating Scale (HAMD) 17 item scale (≥ 16)
- Depressive pseudo dementia
- Mental retardation
- Hydrocephalus
- Epilepsy
- Endogenous psychoses (schizophrenia)
- Untreated or non-compensated hypertension (Blood Pressure systolic > 180 and/or diastolic > 110 mmHg)
- 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)
- Severe heart failure (NYHA: III and IV)
- Arrhythmias (Lown: II-IV, Electrocardiogram > 30 ventricular extrasystoles/hour, multifocal or multiform and repetitive forms of ventricular extrasystoles)
- Bronchial asthma with phases of exacerbation or inducible by aspirin or other Nonsteroidal anti-inflammatory drugs
- 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
- Renal insufficiency: calculated creatinine clearance is less than 60 ml/min
- 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)
- Recent history of liver disease (2 years) including drug intoxication (e.g. narcotics, cytostatics etc.)
- Patients with obvious symptoms of dehydration
- 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)
- Neoplasm currently active or likely to recur (except basal cell carcinoma)
- Participation in another clinical trial within the last four weeks and re-entering from this or a previous talsaclidine trial
- Pregnant and lactating woman, woman with childbearing potential not using an approved method of contraception
- Insufficient compliance: in the investigator's opinion the patient or family is unable to comply with the protocol requirements
About this study
Official title: 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
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
- Conditions
- Alzheimer Disease
- Being tested
- Talsaclidine 6 mg, Talsaclidine 12 mg, Talsaclidine 24 mg, Talsaclidine 36 mg, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talsaclidine 6 mgDrug
Talsaclidine 12 mgDrug
Talsaclidine 24 mgDrug
Talsaclidine 36 mgDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Talsaclidine, 6 mg tid | Experimental | Not described Receives: Drug: Talsaclidine 6 mg |
| Talsaclidine, 12 mg tid | Experimental | Not described Receives: Drug: Talsaclidine 12 mg |
| Talsaclidine, 24 mg tid | Experimental | Not described Receives: Drug: Talsaclidine 24 mg |
| Talsaclidine, 36 mg tid | Experimental | Not described Receives: Drug: Talsaclidine 36 mg |
| Talsaclidine, 36 mg bid | Experimental | Not described Receives: Drug: Talsaclidine 36 mg; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alzheimer's Disease Assessment Scale cognitive part (ADAScog)
Measured: Baseline, week 12
Secondary outcomes (9)
Change in ADAScog (extension)
measures cognitive capability
Measured: Baseline, week 4, 8 and 12
Change in ADAScog (Total)
Defined as ADAScog + ADAScog (Extension)
Measured: Baseline, week 4, 8 and 12
Change in mini mental state (MMS)
Measured: Screening, week 12
Change in neuropsychiatric inventory (NPI)
measures behavioural symptoms
Measured: Baseline, week 12
Change in Hamilton Depression Rating Scale
measures depressive mood
Measured: Screening, week 12
Change in instrumental activity of daily living (IADL)
measures functional performance
Measured: Baseline, week 12
Change in living status rated on a 6-point verbal rating scale
Measured: Baseline, week 12
Change in clinician's global impression rated with Alzheimer's Disease cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)
Measured: Baseline, week 12
Number of patients with adverse events
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startJan 1999
- Primary completionJan 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249403
- Sponsor's protocol ID
- 506.203
- Status last verified
- Sep 2014
- First submitted
- 23 Sep 2014
- Last updated
- 26 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02249403
- Acronym / sponsor ID
- 506.203
- Conditions
- Alzheimer Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 1999
- Primary completion
- Jan 2000 (actual)
- First posted
- 25 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Talsaclidine, 6 mg tid | Experimental | Drug: Talsaclidine 6 mg |
| Talsaclidine, 12 mg tid | Experimental | Drug: Talsaclidine 12 mg |
| Talsaclidine, 24 mg tid | Experimental | Drug: Talsaclidine 24 mg |
| Talsaclidine, 36 mg tid | Experimental | Drug: Talsaclidine 36 mg |
| Talsaclidine, 36 mg bid | Experimental | Drug: Talsaclidine 36 mg, Drug: Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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 non-demented relative or care giver who is willing to support the clinical trial; his/her written informed consent is optional
Key exclusion criteria (35 listed)
- Any dementia of vascular genesis (excluded by Rosen ischemia score > 2)
- 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
- Any stroke history
- All secondary dementia (exclusion diagnosis defined by the NINCDS-ADRDA criteria) as a late complication of:
- Cerebral dysfunction due to metabolic disorders (e.g. unstable thyroid dysfunction, or unstable insulin-dependent diabetes mellitus with hypo-/hyper-glycemic episodes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Talsaclidine 6 mg | Drug | Talsaclidine, 6 mg tid |
| Talsaclidine 12 mg | Drug | Talsaclidine, 12 mg tid |
| Talsaclidine 24 mg | Drug | Talsaclidine, 24 mg tid |
| Talsaclidine 36 mg | Drug | Talsaclidine, 36 mg bid, Talsaclidine, 36 mg tid |
| Placebo | Drug | Placebo, Talsaclidine, 36 mg bid |
Primary outcome
Change in Alzheimer's Disease Assessment Scale cognitive part (ADAScog)
Time frame: Baseline, week 12
9 secondary outcomes
Change in ADAScog (extension)
Time frame: Baseline, week 4, 8 and 12
Change in ADAScog (Total)
Time frame: Baseline, week 4, 8 and 12
Change in mini mental state (MMS)
Time frame: Screening, week 12
Change in neuropsychiatric inventory (NPI)
Time frame: Baseline, week 12
Change in Hamilton Depression Rating Scale
Time frame: Screening, week 12
Change in instrumental activity of daily living (IADL)
Time frame: Baseline, week 12
Change in living status rated on a 6-point verbal rating scale
Time frame: 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
Number of patients with adverse events
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talsaclidine 6 mg, Talsaclidine 12 mg and Talsaclidine 24 mg 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 10 inclusion and 35 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: finished, as of the sponsor's last update on 26 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Alzheimer's Disease Assessment Scale cognitive part (ADAScog) (time frame: Baseline, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2014.