Study to Evaluate Dietary Supplementation With a Version of Anatabloc(R) in Subjects With Alzheimer's Disease (ASAP)

Rock Creek Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Alzheimer Disease

Treatments: Dietary Supplement: Anatabloc(R); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01669876

RCP-009

Details and patient eligibility

About

To explore whether dietary supplementation with a version of Anatabloc(R) exerts an effect on blood levels of amyloid beta (Aβ), or impacts global or functional measures of Alzheimer's Disease (AD) in subjects with mild to moderate AD.

Enrollment: 85 patients

Sex: All

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 65 years old.
• Have a diagnosis of probable AD or a concurrent diagnosis of probable AD and possible or probable vascular dementia.
• Score 16 or more on the Mini-Mental State Examination (MMSE).
• Otherwise stable medical history and general health.
• Weigh between 45 kg and 120 kg inclusive.

Exclusion criteria

• Have contra-indications, allergy, or sensitivity to the study products or their components.
• Be currently taking any of the following medications: systemic (oral or injectable) glucocorticoids; interferon-alpha; anti-CD20 antibody (e.g., rituximab); or anti-CTLA-4 antibody (e.g., ipilimumab).
• Be a current smoker or smokeless tobacco user.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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85 participants in 2 patient groups, including a placebo group

Dietary Supplement: Anatabloc(R)

Active Comparator group

Description:

Study product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day

Treatment:

Dietary Supplement: Anatabloc(R)

Placebo

Placebo Comparator group

Description:

Placebo, as mint-flavored lozenge, to be taken 2-3 times each day

Treatment:

Dietary Supplement: Placebo