NCT02249403

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
362

participants targeted

Target at P75+ for phase_2 alzheimer-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2000

Completed
14.7 years until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2014

Completed
Last Updated

September 26, 2014

Status Verified

September 1, 2014

Enrollment Period

1 year

First QC Date

September 23, 2014

Last Update Submit

September 25, 2014

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

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

    Baseline, week 12

Secondary Outcomes (9)

  • Change in ADAScog (extension)

    Baseline, week 4, 8 and 12

  • Change in ADAScog (Total)

    Baseline, week 4, 8 and 12

  • Change in mini mental state (MMS)

    Screening, week 12

  • Change in neuropsychiatric inventory (NPI)

    Baseline, week 12

  • Change in Hamilton Depression Rating Scale

    Screening, week 12

  • +4 more secondary outcomes

Study Arms (6)

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 mgDrug: Placebo

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Talsaclidine 6 mgDRUG
Talsaclidine, 6 mg tid
Talsaclidine 12 mgDRUG
Talsaclidine, 12 mg tid
Talsaclidine 24 mgDRUG
Talsaclidine, 24 mg tid
Talsaclidine 36 mgDRUG
Talsaclidine, 36 mg bidTalsaclidine, 36 mg tid
PlaceboDRUG
PlaceboTalsaclidine, 36 mg bid

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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)
  • 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 (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
  • Cranio-cerebral trauma
  • Intoxication (incl. history of alcohol and drug abuse)
  • 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
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental 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

January 1, 1999

Primary Completion

January 1, 2000

Last Updated

September 26, 2014

Record last verified: 2014-09