---
title: Assessment Of The Effects Of Single Doses Of An Investigational Drug, Given Alone Or With Donepezil, On Scopolamine-Induced Changes In Memory And Learning In Healthy Adults
nct_id: NCT01345864
overall_status: TERMINATED
phase: PHASE1
sponsor: Pfizer
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01345864.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01345864"
ct_last_update_post_date: 2011-11-17
last_seen_at: "2026-05-12T07:23:10.984Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Assessment Of The Effects Of Single Doses Of An Investigational Drug, Given Alone Or With Donepezil, On Scopolamine-Induced Changes In Memory And Learning In Healthy Adults

**Official Title:** A Randomized, Double-Blind, Sponsor Unblinded, Placebo- And Positive- Controlled Study To Evaluate The Effects Of Single Oral Administrations Of PF-04995274, Alone Or In Combination With Donepezil, On Scopolamine-Induced Deficits In Psychomotor And Cognitive Function In Healthy Adults

**NCT ID:** [NCT01345864](https://clinicaltrials.gov/study/NCT01345864)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** See termination reason in detailed description.
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 88
- **Lead Sponsor:** Pfizer
- **Conditions:** Healthy
- **Start Date:** 2011-05
- **Completion Date:** 2011-08
- **CT.gov Last Update:** 2011-11-17

## Brief Summary

This study is designed to look at the potential for an investigational drug (PF-04995274, under development by Pfizer, Inc. as a potential treatment for Alzheimer's disease) to reverse changes in memory and learning/problem solving skills caused by co-administration of a marketed drug called scopolamine. Scopolamine is known to cause temporary changes in memory and learning/problem solving skills that are similar to those seen in people with alzheimer's disease(AD).

## Detailed Description

Changes in sponsor's organizational strategy have led to the decision to terminate the study and therefore to not conduct the second cohort (Cohort B/arms 2 and 3) . This decision was not based on significant safety concerns. Date of termination (ie, the date the site was notified to stop study activities) was 12 Oct 2011.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 55 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Healthy male or female volunteers; females must be of non-childbearing potential.
* Weight with normal limits for height.
* Willing to comply with study schedule and able to complete 2 practice sessions (pre-study) with computerized memory and learning/problem solving tests.

Exclusion Criteria:

* Positive urine drug screen; concurrent use of prescription or over-the-counter (OTC) drugs or dietary supplements within 7 days or 5 half-lives prior to the first dose of study medication.
* Use of medications with significant serotonergic, cholinergic or anticholinergic side effects \[SSRIs, pyridostigmine, tricyclic antidepressants, meclizine, oxybutynin\]) within 4 weeks of first dose of study drug.
* Glaucoma
* Abnormal electrocardiogram (ECG)
* Treatment with an investigational drug within 30 days of dosing.
```

## Arms

- **Cohort A** (OTHER) — Parallel design with 5 unique treatment groups Donepezil tablets and matching placebo tablets may be overencapsulated as needed.

## Interventions

- **Scopolamine + Donepezil Placebo + PF-04995274 Placebo** (DRUG) — Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1
- **Scopolamine + Donepezil 5 mg + PF-04995274 Placebo** (DRUG) — Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil 5 mg tablet orally x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1
- **Scopolamine + Donepezil 10mg + PF-04995274 Placebo** (DRUG) — Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil 10 mg (2 x 5 mg tablets) orally x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1
- **Scopolamine + Donepezil Placebo + PF-04995274 0.25 mg** (DRUG) — Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 0.25 mg oral liquid x 1 dose on Day 1
- **Scopolamine + Donepezil Placebo + PF-04995274 15 mg** (DRUG) — Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 15 mg oral liquid x 1 dose on day 1

## Primary Outcomes

- **Groton Maze Learning Test (Total Errors)** _(time frame: Day 1 of each period at 8 time points from 0-12 hr postdose relative to scopolamine dosing)_

## Secondary Outcomes

- **Detection Task (Speed; included in CogState test battery)** _(time frame: Day 1 of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing)_
- **Identification Task (Speed; included in CogState test battery)** _(time frame: Day of each period at 8 time points from 0-12 hrs postdose relative to scopolamine dosing)_
- **One Card Learning Task (Accuracy of Performance; included in CogState test battery)** _(time frame: Day 1 of each period at 8 time points from 1-12 hrs postdose relative to scopolamine dosing)_
- **Bond-Lader Visual Analogue Scales** _(time frame: Day 1 of each period at 8 time points from 1-12 hours postdose relative to scopolamine dosing)_

## Locations (1)

- Pfizer Investigational Site, New Haven, Connecticut, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.pfizer investigational site|new haven|connecticut|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01345864.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01345864*  
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