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4 Week, Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (ROBIN)

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 2

Conditions

Mild to Moderate Alzheimer's Disease

Treatments

Drug: Placebo
Drug: AZD1446

Study type

Interventional

Funder types

Industry

Identifiers

NCT01039701
D1950C00006

Details and patient eligibility

About

The primary purpose of the study is to determine the safety and tolerability of AZD1446 vs Placebo given as an add-on treatment to Donepezil for 4 weeks in patients with mild to moderate Alzheimer's disease.

Enrollment

99 patients

Sex

All

Ages

60 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • history of progressive worsening of memory and other cognitive functions for at least 12 months
  • treatment with stable dose of donepezil (10 mg) for at least 3 months
  • the patient should have an appropriate caregiver, who is required for all study visits

Exclusion criteria

  • history of allergy/hypersensitivity reactions
  • significant neurological disease or dementia other than Alzheimer's disease
  • myocardial infarction or acute coronary syndrome within the last year

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

99 participants in 4 patient groups, including a placebo group

1
Experimental group
Description:
AZD1446 60mg once daily + donepezil 10mg
Treatment:
Drug: AZD1446
2
Experimental group
Description:
AZD1446 60mg three times daily + donepezil 10mg
Treatment:
Drug: AZD1446
3
Experimental group
Description:
AZD1446 30mg three times daily + donepezil 10mg
Treatment:
Drug: AZD1446
4
Placebo Comparator group
Description:
placebo + donepezil 10mg
Treatment:
Drug: Placebo

Trial contacts and locations

13

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Data sourced from clinicaltrials.gov

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