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

NCT02249351 | Terminated Phase 2

• 1 other identifier: 506.209
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study to assess symptomatic efficacy, safety and tolerability of talsaclidine in patients with mild to moderate dementia of Alzheimer type

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

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

  Baseline, week 4, 8, 12

Secondary Outcomes (9)

• Change in ADAScog (extension)

  Baseline, week 4, 8, 12

• Change in ADAScog (Total)

  Baseline, week 4, 8, 12

• Change in mini mental state (MMS)

  Screening, week 12

• Change in neuropsychiatric inventory (NP)

  Baseline, week 12

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

  Screening, week 12

Study Arms (2)

Talsaclidine

EXPERIMENTAL

Drug: Talsaclidine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Talsaclidine DRUG

Talsaclidine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• Cranio-cerebral trauma
• Intoxication (incl. history of alcohol and drug abuse)
• 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

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: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2014
• First Posted: September 25, 2014
• Study Start: December 1, 1999
• Primary Completion: May 1, 2000
• Last Updated: September 26, 2014

Record last verified: 2014-09