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Alzheimer DiseasePhase 2NCT02249351

Efficacy and Safety of Talsaclidine (Free Base) in Patients With Mild to Moderate Dementia of Alzheimer Type

A Phase 2 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

Study to assess symptomatic efficacy, safety and tolerability of talsaclidine in patients with mild to moderate dementia of Alzheimer type 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
No sites listed yet
Study dates
Dec 1999to May 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 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)
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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 (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)
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  • 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

About this study

Official title: 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

Being tested
Talsaclidine, 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.

  • TalsaclidineDrug

  • PlaceboDrug

Study groups in NCT02249351
Study groupRoleWhat they receive
TalsaclidineExperimentalNot described
Receives: Drug: Talsaclidine
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Change in Alzheimer's Disease Assessment Scale cognitive part (ADAScog)

    Measured: Baseline, week 4, 8, 12

Secondary outcomes (9)

  1. Change in ADAScog (extension)

    Measured: Baseline, week 4, 8, 12

  2. Change in ADAScog (Total)

    Defined as ADAScog + ADAScog(extension)

    Measured: Baseline, week 4, 8, 12

  3. Change in mini mental state (MMS)

    Measured: Screening, week 12

  4. Change in neuropsychiatric inventory (NP)

    Measured: Baseline, week 12

  5. Change in Hamilton Depression Rating Scale (HAMD 17 item scale)

    Measured: Screening, week 12

  6. Change in instrumental activity of daily living (IADL)

    Measured: Baseline, week 12

  7. Change in living status rated on a 6-point scale

    Measured: Baseline, week 12

  8. Change in clinician's global impression rated with Alzheimer's Disease cooperative Study - Clinical Global Impression of Change (ADCS-CGIC)

    Measured: Baseline, week 12

  9. Number of patients with adverse events

    Measured: up to 6 months

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 startDec 1999
  3. Primary completionMay 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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02249351
Sponsor's protocol ID
506.209
Status last verified
Sep 2014
First submitted
23 Sep 2014
Last updated
26 Sep 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 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 10 inclusion and 46 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 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 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?

Change in Alzheimer's Disease Assessment Scale cognitive part (ADAScog) (time frame: Baseline, week 4, 8, 12). 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 NCT02249351.

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.

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